A Phase 2 interventional study of Pegilodecakin and Nivolumab in Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Terminated at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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Among 147 studies in Carcinoma, Non-Small-Cell Lung by Eli Lilly and Company — 6 open to participants now, 20 under way, 6 of them phase 3. Carcinoma, Non-Small-Cell Lung · Eli Lilly and Company.
Among the 147 studies in Carcinoma, Non-Small-Cell Lung by Eli Lilly and Company, this one is the 102nd largest by enrollment of the 139 interventional ones that give a count, is one of 2 that started in 2018, is one of 73 in phase 2, and was the 123rd registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →6 of the 147 studies in Carcinoma, Non-Small-Cell Lung by Eli Lilly and Company are open now, in 12 countries. Recruiting first, the newest first:
Eli Lilly and Company · Sites in United States, Australia, Austria and 26 more countries
Ages 18+
Eli Lilly and Company · Sites in United States, Australia, China and 5 more countries
Ages 18+
Eli Lilly and Company · Sites in United States, Australia, France and 4 more countries
Ages 18+
Eli Lilly and Company · Sites in United States, Australia, Austria and 26 more countries
Ages 18+
Eli Lilly and Company · Sites in United States, France, Japan and 2 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
147 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 41 · Phase 2 86 · Phase 3 25 · Phase 4 3
First in 2000; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 109 across the 139 interventional studies, 1,076 across the 2 observational. Of the 121 that completed or were terminated, 81 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
5 of the studies in Carcinoma, Non-Small-Cell Lung by Eli Lilly and Company that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06119581Phase 3Eli Lilly and CompanyA Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer | 2027-11 |
| NCT06238479Eli Lilly and CompanyA Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT04956640Eli Lilly and CompanyStudy of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) | 2027-04 |
| NCT06465069Eli Lilly and CompanyA Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors | 2027-05 |
| NCT06561685Eli Lilly and CompanyA Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors | 2027-10 |
Add all 5 to your calendar (.ics) → With an account.
Among the 147 studies in Carcinoma, Non-Small-Cell Lung by Eli Lilly and Company, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of PD-L1 (0-49%).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Biological: Pegilodecakin · Drug: Nivolumab
Participants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Drug: Nivolumab
Pegilodecakin plus Nivolumab
Also known as: LY3500518, AM0010
Nivolumab Alone
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Time frame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)
Overall Survival (OS)
OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Time frame: From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Progression Free Survival (PFS)
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
Time frame: From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Time frame: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)
Duration of Response
Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
Time frame: From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
| Milestone | Pegilodecakin+Nivolumab | Nivolumab |
|---|---|---|
| Started | 27 | 25 |
| Received at least 1 dose of study drug | 27 | 24 |
| Completed | 21 | 13 |
| Not completed | 6 | 12 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Sponsor decision | 6 | 6 |
| Withdrew: Withdrawal by subject | 0 | 5 |
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
| Percentage of participants | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 14.8 (4.2 to 33.7) | 12.0 (2.6 to 31.2) |
OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
| Months | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| Overall Survival (OS) | 1.87 (1.51 to 3.58) | 1.94 (1.71 to 2.17) |
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
| Months | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| Progression Free Survival (PFS) | 6.70 (3.09 to NA) | 10.74 (4.21 to NA) |
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
| Percentage of participants | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | 37.0 (19.4 to 57.6) | 28.0 (12.1 to 49.4) |
Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
| Months | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| Duration of Response | NA (7.36 to NA) | 3.06 (1.87 to NA) |
Collected over Up to 23 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegilodecakin + Nivolumab | 15/27 (55.6%) | 13/27 (48.1%) | 27/27 (100%) |
| Nivolumab | 12/24 (50%) | 9/24 (37.5%) | 22/24 (91.7%) |
| Event | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/27 | 1/24 |
| PneumoniaInfections and infestations | 1/27 | 3/24 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/27 | 2/24 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/27 | 2/24 |
| FallInjury, poisoning and procedural complications | 2/27 | 0/24 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/27 | 0/24 |
| Cardiac arrestCardiac disorders | 0/27 | 1/24 |
| Cardio-respiratory arrestCardiac disorders | 0/27 | 1/24 |
| TachycardiaCardiac disorders | 0/27 | 1/24 |
| Pleural infectionInfections and infestations | 0/27 | 1/24 |
| Event | Pegilodecakin + Nivolumab | Nivolumab |
|---|---|---|
| FatigueGeneral disorders | 17/27 | 10/24 |
| AnaemiaBlood and lymphatic system disorders | 14/27 | 5/24 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 14/27 | 10/24 |
| Decreased appetiteMetabolism and nutrition disorders | 11/27 | 7/24 |
| PyrexiaGeneral disorders | 8/27 | 4/24 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/27 | 4/24 |
| ConstipationGastrointestinal disorders | 7/27 | 5/24 |
| DizzinessNervous system disorders | 7/27 | 4/24 |
| HypotensionVascular disorders | 7/27 | 6/24 |
| VomitingGastrointestinal disorders | 6/27 | 2/24 |
All randomized participants.
| Age, Continuous(years) | Pegilodecakin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Mean | 68.4 ± 8.2 | 65.9 ± 10.4 | 67.2 ± 9.3 |
| Sex: Female, Male(Participants) | Pegilodecakin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 17 | 14 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Pegilodecakin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 24 | 20 | 44 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Pegilodecakin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 23 | 20 | 43 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(Participants) | Pegilodecakin + Nivolumab | Nivolumab | Total |
|---|---|---|---|
| United States | 27 | 25 | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Yes Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Mar 2018 to primary completion in Aug 2019, 17 months.
Results were first posted in Sep 2020, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegilodecakin
Carcinoma, Non-Small-Cell Lung →