CompletedNCT00762034Updated Dec 21, 2015Results posted

A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer

A Phase 3 interventional study of Pemetrexed and Pemetrexed in Non-small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 67 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-21.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 939
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Conditions studied

Non-small Cell Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 939 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

You must sign an informed consent document for clinical research.
You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.
You must not have received any prior treatment for your disease.
Prior radiation therapy is allowed to \< 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.
You must be at least 18 years of age or older.
You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT) scan.
Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.
Women must be sterile, postmenopausal or on contraception and men must be sterile (for example post-vasectomy) or on contraception.

Exclusion criteria

Exclusion Criteria:

You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell histology.
You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.
You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.
You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
You are currently receiving ongoing treatment with full-dose warfarin or equivalent.
You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.
You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.
You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
You cannot have received an investigational treatment within 30 days prior to the trial.
You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.
You cannot be pregnant or breast-feeding.
You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the trial.
You are unable to stop taking aspirin more than 1.3 grams per day or other nonsteroidal anti-inflammatory drugs (NSAIDs).
You are unable or unwilling to take folic acid or vitamin B12 supplementation.
You are unable to take corticosteroids.
You have any other on-going illnesses including active infections that may not allow you to adhere to the requirements of the trial.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 939 participants (actual)

Study arms

Experimental
Pem/Carbo/Bev
Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Drug: Pemetrexed · Drug: Carboplatin · Biological: Bevacizumab
Active comparator
Pac/Carbo/Bev
Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Drug: Paclitaxel · Drug: Carboplatin · Biological: Bevacizumab

Interventions

DrugPemetrexed
Induction therapy 500 milligram per meter squared (mg/m\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Also known as: Alimta, LY231514
DrugPemetrexed
Maintenance therapy 500 mg/m\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Also known as: Alimta, LY231514
DrugPaclitaxel
Induction therapy 200 mg/m\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
DrugCarboplatin
Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
BiologicalBevacizumab
Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
BiologicalBevacizumab
Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.

What researchers measure

Primary outcomes

Overall Survival
Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time frame: Baseline to date of death from any cause (up to 37.06 months)

Secondary outcomes

Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Time frame: Baseline to measured progressive disease (up to 37.06 months)
Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)
Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.
Time frame: Baseline to measured progressive disease (up to 37.06 months)
Progression Free Survival Time
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Time frame: Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)
Time to Progressive Disease
Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Time frame: Baseline to measured progressive disease (up to 37.06 months)
Safety and Toxicity Profile of Study Treatments
Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Time frame: Baseline to study endpoint (up to 37.06 months)
Duration of Hospitalizations Per Participant
Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.
Time frame: Baseline to study endpoint (up to 37.06 months)
Number of Participants Who Received a Transfusion
Time frame: Baseline to study endpoint (up to 37.06 months)
Number of Participants Receiving Concomitant Medication
Time frame: Baseline to study endpoint (up to 37.06 months)
Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)
The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.
Time frame: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)
FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.
Time frame: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)
FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items; each uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.
Time frame: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed
Time frame: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed
Time frame: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed
Time frame: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Pharmacokinetics (PK): Pemetrexed Clearance (CL)
Time frame: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum
Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.
Time frame: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum
Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.
Time frame: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum
Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.
Time frame: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms
Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.
Time frame: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab
Time frame: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab
Time frame: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab
Time frame: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Pharmacokinetics (PK): Bevacizumab Clearance (CL)
Time frame: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).
Time frame: Baseline
Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment
Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score \>0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time frame: Baseline to date of death from any cause (up to 37.06 months)
Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression
Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score \>0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time frame: Baseline to date of death from any cause (up to 37.06 months)
Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression
Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score \>0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time frame: Baseline to date of death from any cause (up to 37.06 months)

Results

Posted Nov 28, 2013

Participant flow

Induction Period

Participant flow — Induction Period
Milestone	Pem/Carbo/Bev	Pac/Carbo/Bev
Started	472	467
Received at least 1 dose of study drug	442	443
Completed	294	298
Not completed	178	169
Withdrew: Protocol violation	1	2
Withdrew: Entry criterion not met	12	11
Withdrew: Adverse event	27	38
Withdrew: Lost to follow-up	1	1
Withdrew: Progressive disease	73	55
Withdrew: Physician decision	21	20
Withdrew: Withdrawal by subject	15	19
Withdrew: Deaths not due to study disease	19	14
Withdrew: Deaths due to study disease	9	9

Maintenance Period

Participant flow — Maintenance Period
Milestone	Pem/Carbo/Bev	Pac/Carbo/Bev
Started	294	298
Received at least 1 dose of study drug	294	298
Completed	0	0
Not completed	294	298
Withdrew: Protocol violation	1	3
Withdrew: Entry criterion not met	0	2
Withdrew: Adverse event	42	26
Withdrew: Progressive disease	186	224
Withdrew: Physician decision	25	20
Withdrew: Withdrawal by subject	34	14
Withdrew: Death not due to study disease	2	5
Withdrew: Death due to study disease	3	3
Withdrew: Other	1	1

Outcome measures

PrimaryOverall Survival

Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.

Time frame:: Baseline to date of death from any cause (up to 37.06 months)
Reported as:: Median · months

Overall Survival
months	Pem/Carbo/Bev	Pac/Carbo/Bev
Overall Survival	12.55 (11.30 to 14.03)	13.40 (11.86 to 14.91)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Log Rank · p = 0.94896 · Hazard ratio (hr): 1.00 · 95% CI 0.86 to 1.16

SecondaryPercentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)

Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.

Time frame:: Baseline to measured progressive disease (up to 37.06 months)
Reported as:: Number · percentage of participants

Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
percentage of participants	Pem/Carbo/Bev	Pac/Carbo/Bev
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)	34.1 (29.8 to 38.6)	33.0 (28.7 to 37.4)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Fisher Exact · p = 0.72997

SecondaryPercentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)

Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.

Time frame:: Baseline to measured progressive disease (up to 37.06 months)
Reported as:: Number · percentage of participants

Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)
percentage of participants	Pem/Carbo/Bev	Pac/Carbo/Bev
Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)	65.9 (61.4 to 70.2)	69.8 (65.4 to 73.9)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Fisher Exact · p = 0.20892

SecondaryProgression Free Survival Time

Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.

Time frame:: Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)
Reported as:: Median · months

Progression Free Survival Time
months	Pem/Carbo/Bev	Pac/Carbo/Bev
Progression Free Survival Time	6.04 (5.55 to 6.87)	5.55 (5.39 to 5.98)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Log Rank · p = 0.01206 · Hazard ratio (hr): 0.83 · 95% CI 0.71 to 0.96

SecondaryTime to Progressive Disease

Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.

Time frame:: Baseline to measured progressive disease (up to 37.06 months)
Reported as:: Median · months

Time to Progressive Disease
months	Pem/Carbo/Bev	Pac/Carbo/Bev
Time to Progressive Disease	7.03 (6.24 to 8.05)	6.04 (5.58 to 6.87)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Log Rank · p = 0.006 · Hazard ratio (hr): 0.79 · 95% CI 0.67 to 0.94

SecondarySafety and Toxicity Profile of Study Treatments

Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.

Time frame:: Baseline to study endpoint (up to 37.06 months)
Reported as:: Number · participants

Safety and Toxicity Profile of Study Treatments
participants	Pem/Carbo/Bev; Induction Phase	Pem/Carbo/Bev; Maintenance Phase	Pac/Carbo/Bev; Induction Phase	Pac/Carbo/Bev; Maintenance Phase
Serious Adverse Events (SAEs)	111	83	123	68
Other Adverse Events (AEs)	432	288	431	296

SecondaryDuration of Hospitalizations Per Participant

Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.

Time frame:: Baseline to study endpoint (up to 37.06 months)
Reported as:: Mean · days

Duration of Hospitalizations Per Participant
days	Pem/Carbo/Bev	Pac/Carbo/Bev
Duration of Hospitalizations Per Participant	9.4 ± 9.8	8.0 ± 6.7

SecondaryNumber of Participants Who Received a Transfusion

Time frame:: Baseline to study endpoint (up to 37.06 months)
Reported as:: Number · participants

Number of Participants Who Received a Transfusion
participants	Pem/Carbo/Bev	Pac/Carbo/Bev
Number of Participants Who Received a Transfusion	116	44

SecondaryNumber of Participants Receiving Concomitant Medication

Time frame:: Baseline to study endpoint (up to 37.06 months)
Reported as:: Number · participants

Number of Participants Receiving Concomitant Medication
participants	Pem/Carbo/Bev	Pac/Carbo/Bev
Number of Participants Receiving Concomitant Medication	406	421

SecondaryChange From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)

The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.

Time frame:: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)
units on a scale	Pem/Carbo/Bev	Pac/Carbo/Bev
Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)	0.51 ± 0.54	0.18 ± 0.54

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Mixed Models Analysis · p = 0.667 (Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.)

SecondaryChange From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)

FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.

Time frame:: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)
units on a scale	Pem/Carbo/Bev	Pac/Carbo/Bev
FACT-L Total Score (n=397, 392)	1.88 ± 0.65	1.66 ± 0.66
Trial Outcome Index-Lung (TOI-L) (n=396, 394)	-0.38 ± 0.50	-0.40 ± 0.50

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Mixed Models Analysis · p = 0.815 (p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.)
Pem/Carbo/Bev vs Pac/Carbo/Bev · Mixed Models Analysis · p = 0.978 (p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.)

SecondaryChange From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)

FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items; each uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.

Time frame:: Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)
units on a scale	Pem/Carbo/Bev	Pac/Carbo/Bev
FACT/GOG-Ntx Total Score (n=393, 389)	-0.60 ± 0.70	-5.48 ± 0.70
Ntx Trial Outcome Index (TOI-Ntx)(n=393, 390)	-2.79 ± 0.55	-7.60 ± 0.55

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Mixed Models Analysis · p = <0.001 (p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.)
Pem/Carbo/Bev vs Pac/Carbo/Bev · Mixed Models Analysis · p = <0.001 (p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.)

SecondaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed

Time frame:: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Reported as:: Geometric mean · micrograms per milliliter (μg/mL)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed
micrograms per milliliter (μg/mL)	Pem/Carbo/Bev
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed	122 ± 20

SecondaryPharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed

Time frame:: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Reported as:: Geometric mean · hours (hr)

Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed
hours (hr)	Pem/Carbo/Bev
Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed	2.88 ± 13

SecondaryPharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed

Time frame:: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Reported as:: Geometric mean · microgram*hour per milliliter (μg•hr/mL)

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed
microgram*hour per milliliter (μg•hr/mL)	Pem/Carbo/Bev
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed	203 ± 23

SecondaryPharmacokinetics (PK): Pemetrexed Clearance (CL)

Time frame:: Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)
Reported as:: Geometric mean · milliliters per minute (mL/min)

Pharmacokinetics (PK): Pemetrexed Clearance (CL)
milliliters per minute (mL/min)	Pem/Carbo/Bev
Pharmacokinetics (PK): Pemetrexed Clearance (CL)	72.1 ± 25

SecondaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum

Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.

Time frame:: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Reported as:: Geometric mean · micrograms per milliliter (μg/mL)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum
micrograms per milliliter (μg/mL)	Pem/Carbo/Bev	Pac/Carbo/Bev
Total (Bound and Unbound)	18.4 ± 24	17.8 ± 33
Unbound (n=18, 15)	21.1 ± 31	17.1 ± 34

SecondaryPharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum

Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.

Time frame:: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Reported as:: Geometric mean · hours (hr)

Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum
hours (hr)	Pem/Carbo/Bev	Pac/Carbo/Bev
Total (Bound and Unbound)	65.6 ± 69	86.4 ± 21
Unbound (n=17, 13)	2.03 ± 15	1.95 ± 21

SecondaryPharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum

Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.

Time frame:: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Reported as:: Geometric mean · microgram*hour per milliliter (μg•hr/mL)

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum
microgram*hour per milliliter (μg•hr/mL)	Pem/Carbo/Bev	Pac/Carbo/Bev
Total (Bound and Unbound)	160 ± 32	182 ± 24
Unbound (n=17, 13)	55.7 ± 33	62.9 ± 34

SecondaryPharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms

Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.

Time frame:: Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)
Reported as:: Geometric mean · liters per hour (L/hr)

Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms
liters per hour (L/hr)	Pem/Carbo/Bev	Pac/Carbo/Bev
Total (Bound and Unbound)	2.02 ± 39	1.87 ± 28
Unbound (n=17, 13)	5.81 ± 35	5.36 ± 47

SecondaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab

Time frame:: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Reported as:: Geometric mean · micrograms per milliliter (μg/mL)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab
micrograms per milliliter (μg/mL)	Pem/Carbo/Bev	Pac/Carbo/Bev
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab	276 ± 18	302 ± 20

SecondaryPharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab

Time frame:: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Reported as:: Geometric mean · days

Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab
days	Pem/Carbo/Bev	Pac/Carbo/Bev
Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab	14.8 ± 36	12.8 ± 46

SecondaryPharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab

Time frame:: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Reported as:: Geometric mean · microgram*day per milliliter (μg•day/mL)

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab
microgram*day per milliliter (μg•day/mL)	Pem/Carbo/Bev	Pac/Carbo/Bev
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab	3070 ± 29	3160 ± 33

SecondaryPharmacokinetics (PK): Bevacizumab Clearance (CL)

Time frame:: Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)
Reported as:: Geometric mean · liters per day (L/day)

Pharmacokinetics (PK): Bevacizumab Clearance (CL)
liters per day (L/day)	Pem/Carbo/Bev	Pac/Carbo/Bev
Pharmacokinetics (PK): Bevacizumab Clearance (CL)	0.341 ± 31	0.376 ± 38

SecondaryTranslational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations

Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).

Time frame:: Baseline
Reported as:: Number · participants

Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
participants	Pem or Pac Plus Carbo/Bev
EGFR mutation positive	11
EGFR mutation negative	121

SecondaryTranslational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment

Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score \>0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.

Time frame:: Baseline to date of death from any cause (up to 37.06 months)
Reported as:: Median · months

Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment
months	TTF-1 Positive (H Score > 0)	TTF-1 Negative (H Score = 0)
Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment	14.9 (12.8 to 17.6)	8.7 (6.4 to 10.5)

Statistical analysis

TTF-1 Positive (H Score > 0) vs TTF-1 Negative (H Score = 0) · Regression, Cox · p = <0.001 (p-value was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.480 · 95% CI 0.338 to 0.681

SecondaryTranslational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression

Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score \>0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.

Time frame:: Baseline to date of death from any cause (up to 37.06 months)
Reported as:: Median · months

Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression
months	Pem/Carbo/Bev	Pac/Carbo/Bev
TS Cytoplasm Positive (H score > 0; n=90, 83)	12.9 (10.8 to 16.9)	12.4 (10.9 to 15.5)
TS Cytoplasm Negative (H score = 0; n=10, 6)	18.2 (12.5 to NA)	11.6 (9.1 to 14.7)
TS Nucleus Positive (H score > 0; n=68, 51)	12.7 (9.7 to 15.4)	12.4 (8.4 to 15.5)
TS Nucleus Negative (H score = 0; n=32, 38)	19.2 (12.5 to 24.1)	12.4 (10.1 to 17.1)

Statistical analysis

Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.673 (p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.927 · 95% CI 0.654 to 1.316
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.287 (p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.521 · 95% CI 0.157 to 1.729
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.2 (p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.759 · 95% CI 0.498 to 1.157
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.915 (p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.969 · 95% CI 0.540 to 1.738

SecondaryTranslational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression

Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score \>0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.

Time frame:: Baseline to date of death from any cause (up to 37.06 months)
Reported as:: Median · months

Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression
months	Pem/Carbo/Bev	Pac/Carbo/Bev
FR-α Cytoplasm Positive (H score > 0; n=64, 53)	14.4 (11.4 to 22.2)	14.3 (11.2 to 18.2)
FR-α Cytoplasm Negative (H score = 0; n=34, 29)	12.0 (9.6 to 16.9)	11.2 (5.7 to 14.4)
FR-α Membrane Positive (H score > 0; n=39, 22)	19.2 (10.5 to 30.8)	15.5 (11.2 to NA)
FR-α Membrane Negative (H score = 0; n=59, 60)	12.9 (9.6 to 16.7)	11.3 (8.8 to 14.7)

Statistical analysis

Pac/Carbo/Bev · Regression, Cox · p = 0.891 (p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.970 · 95% CI 0.622 to 1.511
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.060 (p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.592 · 95% CI 0.342 to 1.023
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.905 (p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.960 · 95% CI 0.490 to 1.880
Pem/Carbo/Bev vs Pac/Carbo/Bev · Regression, Cox · p = 0.455 (p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.) · Hazard ratio (hr): 0.859 · 95% CI 0.575 to 1.281

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pem/Carbo/Bev	—	188/442 (42.5%)	430/442 (97.3%)
Pac/Carbo/Bev	—	181/443 (40.9%)	433/443 (97.7%)

Most frequent serious events

Showing 10 of 256

Most frequent serious events
Event	Pem/Carbo/Bev	Pac/Carbo/Bev
PneumoniaInfections and infestations	28/442	27/443
DehydrationMetabolism and nutrition disorders	20/442	21/443
AnaemiaBlood and lymphatic system disorders	18/442	5/443
Deep vein thrombosisVascular disorders	5/442	14/443
VomitingGastrointestinal disorders	13/442	11/443
Febrile neutropeniaBlood and lymphatic system disorders	6/442	13/443
ThrombocytopeniaBlood and lymphatic system disorders	12/442	3/443
Respiratory failureRespiratory, thoracic and mediastinal disorders	11/442	4/443
NauseaGastrointestinal disorders	9/442	11/443
NeutropeniaBlood and lymphatic system disorders	10/442	9/443

Most frequent other events

Showing 10 of 61

Most frequent other events
Event	Pem/Carbo/Bev	Pac/Carbo/Bev
FatigueGeneral disorders	268/442	257/443
NauseaGastrointestinal disorders	236/442	223/443
NeutropeniaBlood and lymphatic system disorders	170/442	219/443
AlopeciaSkin and subcutaneous tissue disorders	34/442	193/443
ConstipationGastrointestinal disorders	181/442	166/443
AnaemiaBlood and lymphatic system disorders	177/442	136/443
ThrombocytopeniaBlood and lymphatic system disorders	159/442	105/443
Decreased appetiteMetabolism and nutrition disorders	133/442	145/443
Neuropathy peripheralNervous system disorders	42/442	145/443
DiarrhoeaGastrointestinal disorders	100/442	118/443

Baseline characteristics

All randomized participants.

Age, Customized
Age, Customized(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
<=65 years	249	236	485
>65 years	223	231	454

Sex: Female, Male
Sex: Female, Male(Participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
Female	221	218	439
Male	251	249	500

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
Caucasian	409	396	805
Black or African American	42	52	94
Asian	15	14	29
American Indian or Alaska Native	1	1	2
Multiple race/ethnicities	2	3	5
Information not provided	3	1	4

Region of Enrollment
Region of Enrollment(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
United States	472	467	939

Previously Treated Brain Metastasis
Previously Treated Brain Metastasis(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
Yes	52	52	104
No	420	415	835

Histological Subtype
Histological Subtype(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
Adenocarcinoma, Lung	367	360	727
Bronchioalveolar Carcinoma	4	3	7
Large Cell Lung Carcinoma	8	15	23
NSCLC Not Otherwise Specified	47	39	86
NSCLC Poorly Differentiated	39	47	86
Predominantly Adenocarcinoma	7	2	9
Unknown	0	1	1

Histological Category for Subgroup Analyses
Histological Category for Subgroup Analyses(participants)	Pem/Carbo/Bev	Pac/Carbo/Bev	Total
Adenocarcinoma	378	365	743
Large Cell Carcinoma	8	15	23
Other or Indeterminant	86	86	172
Unknown	0	1	1

Study locations

67 sites

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Fayetteville, Arkansas 72703, United States
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Jonesboro, Arkansas 72401, United States
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Alhambra, California 91801, United States
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Bakersfield, California 93309, United States
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Duarte, California 91010, United States
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Fountain Valley, California 92708, United States
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Fullerton, California 92835, United States
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La Verne, California 91750, United States
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Long Beach, California 90813, United States
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Los Angeles, California 90095, United States
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Northridge, California 91325, United States
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Rancho Mirage, California 92270, United States
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Redondo Beach, California 90277, United States
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Santa Barbara, California 93105, United States
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Santa Maria, California 93454, United States
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Santa Rosa, California 95403, United States
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Grand Junction, Colorado 81501, United States
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Boca Raton, Florida 33486, United States
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Coral Springs, Florida 33065, United States
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Fort Myers, Florida 33916, United States
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Jacksonville, Florida 32256, United States
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Lake Worth, Florida 33467, United States
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Melbourne, Florida 32901, United States
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Orlando, Florida 32804, United States
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Pembroke Pines, Florida 33028, United States
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Port St Lucie, Florida 34952, United States
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Stuart, Florida 34994, United States
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Athens, Georgia 30607, United States
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Augusta, Georgia 30901, United States
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Fort Gordon, Georgia 30905, United States
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Chicago, Illinois 60612, United States
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Gurnee, Illinois 60031, United States
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Skokie, Illinois 60077, United States
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New Albany, Indiana 47150, United States
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Wichita, Kansas 67214, United States
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Louisville, Kentucky 40205, United States
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Baton Rouge, Louisiana 70809, United States
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Baltimore, Maryland 21237, United States
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Bethesda, Maryland 20817, United States
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Chevy Chase, Maryland 20815, United States
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Frederick, Maryland 21701, United States
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Rockville, Maryland 20850, United States
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Boston, Massachusetts 02115, United States
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Framingham, Massachusetts 01701, United States
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Lambertville, Michigan 48144, United States
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Duluth, Minnesota 55805, United States
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Minneapolis, Minnesota 55417, United States
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St Louis, Missouri 63110, United States
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Reno, Nevada 89502, United States
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Bronx, New York 10467, United States
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Stony Brook, New York 11794, United States
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Chapel Hill, North Carolina 27514, United States
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Cincinnati, Ohio 45242, United States
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Columbus, Ohio 43219, United States
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Oklahoma City, Oklahoma 73120, United States
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Tulsa, Oklahoma 74136, United States
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Kittanning, Pennsylvania 16201, United States
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Willow Grove, Pennsylvania 19090, United States
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Columbia, South Carolina 29210, United States
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Knoxville, Tennessee 37920, United States
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Memphis, Tennessee 38120, United States
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San Antonio, Texas 78229, United States
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The Woodlands, Texas 77380, United States
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Abingdon, Virginia 24211, United States
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Richmond, Virginia 23230, United States
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Tacoma, Washington 98405, United States
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Milwaukee, Wisconsin 53226, United States

References and documents

Publications

Spigel DR, Patel JD, Reynolds CH, Garon EB, Hermann RC, Govindan R, Olsen MR, Winfree KB, Chen J, Liu J, Guba SC, Socinski MA, Bonomi P. Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):353-9. doi: 10.1097/JTO.0000000000000277. PubMed 25611228 ↗
Reynolds CH, Patel JD, Garon EB, Olsen MR, Bonomi P, Govindan R, Pennella EJ, Liu J, Guba SC, Li S, Spigel DR, Hermann RC, Socinski MA, Obasaju CK. Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18. PubMed 25516338 ↗
Patel JD, Socinski MA, Garon EB, Reynolds CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA, Guba SC, Liu J, Frimodt-Moller B, John WJ, Obasaju CK, Pennella EJ, Bonomi P, Govindan R. PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21. PubMed 24145346 ↗
Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C, Pennella EJ, Girvan AC, Guba SC. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2009 Jul;10(4):252-6. doi: 10.3816/CLC.2009.n.035. PubMed 19632943 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00762034
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Sep 30, 2008
Start date: Dec 2008
Primary completion: Apr 2012
Completion: Dec 2014
Results posted: Nov 28, 2013
Last update: Dec 21, 2015

Study contacts

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study director · Eli Lilly and Company

Oversight

Data monitoring committee: Yes

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A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer

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