A Phase 2 interventional study of Pegilodecakin and Pembrolizumab in Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Terminated at 74 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
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 74th 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 101 is above 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 pembrolizumab versus pembrolizumab 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 pembrolizumab versus pembrolizumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with high expression of PD-L1 (> 50%).
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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 (SQ) 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. Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.
Biological: Pegilodecakin · Drug: Pembrolizumab
Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.
Drug: Pembrolizumab
Pegilodecakin plus Pembrolizumab
Also known as: LY3500518, AM0010
Pembrolizumab Alone
Percentage of Participants Who Achieved an Objective Response Rate (ORR)
ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
Time frame: From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months)
Overall Survival (OS)
OS is defined as the time from date of randomization to death due to any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were 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 24 Months)
Progression Free Survival (PFS)
PFS is defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause. Progressive disease (PD) is defined by at least a 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters or the presence of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression determined by scans. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow up before documented progression and death or were censored at the date of last adequate tumor assessment, participants or new anticancer therapy started and not tumor progression or death were censored at the last adequate tumor assessment before the start of new anticancer therapy.
Time frame: From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months)
Percentage of Participants Who Achieved a Disease Control Rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have achieved a complete response (CR), partial response (PR) or stable disease (SD) response prior to disease progression. CR is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters. SD is defined as neither sufficient shrinkage of target lesions to qualify for partial response, nor sufficient increase to qualify for progressive disease, taking as reference the baseline sum of longest diameters.
Time frame: From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months)
Duration of Response (DOR)
DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Duration of response was analyzed in participants who had CR or PR. Duration of response was censored on the date of the last tumor assessment on trial for participants who did not have objective tumor progression and who did not die due to any cause while on trial. For participants who discontinued participation in the trial or discontinued from tumor scan assessments before disease progression, the duration of response was censored at the date of the last tumor assessment.
Time frame: From Date of Response to Death Due to Any Cause (Up to 24 Months)
| Milestone | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Started | 51 | 50 |
| Received at least 1 dose of study drug | 50 | 48 |
| Completed | 20 | 15 |
| Not completed | 31 | 35 |
| Withdrew: Ineligibility determined | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Sponsor's decision | 31 | 28 |
| Withdrew: Withdrawal by subject | 0 | 5 |
ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.
| percentage of participants | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Response Rate (ORR) | 47.1 (32.9 to 61.5) | 44.0 (30.0 to 58.8) |
OS is defined as the time from date of randomization to death due to any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the participant was known to be alive.
| Months | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Overall Survival (OS) | 16.33 (10.51 to NA) | NA (NA to NA) |
PFS is defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause. Progressive disease (PD) is defined by at least a 20% increase in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters or the presence of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression determined by scans. Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow up before documented progression and death or were censored at the date of last adequate tumor assessment, participants or new anticancer therapy started and not tumor progression or death were censored at the last adequate tumor assessment before the start of new anticancer therapy.
| Months | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Progression Free Survival (PFS) | 6.28 (2.86 to NA) | 6.08 (2.23 to NA) |
DCR is defined as the percentage of participants in the analysis population who have achieved a complete response (CR), partial response (PR) or stable disease (SD) response prior to disease progression. CR is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters. SD is defined as neither sufficient shrinkage of target lesions to qualify for partial response, nor sufficient increase to qualify for progressive disease, taking as reference the baseline sum of longest diameters.
| percentage of participants | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Percentage of Participants Who Achieved a Disease Control Rate (DCR) | 62.7 (48.1 to 75.9) | 62.0 (47.2 to 75.4) |
DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first. Duration of response was analyzed in participants who had CR or PR. Duration of response was censored on the date of the last tumor assessment on trial for participants who did not have objective tumor progression and who did not die due to any cause while on trial. For participants who discontinued participation in the trial or discontinued from tumor scan assessments before disease progression, the duration of response was censored at the date of the last tumor assessment.
| Months | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| Duration of Response (DOR) | 14.23 (2.50 to 14.23) | NA (4.14 to NA) |
Collected over Baseline Up To 24 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegilodecakin + Pembrolizumab | 19/50 (38%) | 28/50 (56%) | 48/50 (96%) |
| Pembrolizumab | 13/48 (27.1%) | 25/48 (52.1%) | 48/48 (100%) |
| Event | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| PneumoniaInfections and infestations | 9/50 | 6/48 |
| SepsisInfections and infestations | 5/50 | 0/48 |
| DehydrationMetabolism and nutrition disorders | 5/50 | 0/48 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/50 | 4/48 |
| AnaemiaBlood and lymphatic system disorders | 4/50 | 1/48 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/50 | 3/48 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/50 | 3/48 |
| HyponatraemiaMetabolism and nutrition disorders | 3/50 | 1/48 |
| HypotensionVascular disorders | 3/50 | 0/48 |
| DiarrhoeaGastrointestinal disorders | 0/50 | 2/48 |
| Event | Pegilodecakin + Pembrolizumab | Pembrolizumab |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 30/50 | 10/48 |
| FatigueGeneral disorders | 27/50 | 23/48 |
| Decreased appetiteMetabolism and nutrition disorders | 19/50 | 16/48 |
| ConstipationGastrointestinal disorders | 5/50 | 16/48 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 16/50 | 13/48 |
| ThrombocytopeniaBlood and lymphatic system disorders | 14/50 | 5/48 |
| NauseaGastrointestinal disorders | 14/50 | 10/48 |
| CoughRespiratory, thoracic and mediastinal disorders | 11/50 | 13/48 |
| PyrexiaGeneral disorders | 13/50 | 3/48 |
| RashSkin and subcutaneous tissue disorders | 13/50 | 7/48 |
All randomized participants.
| Age, Continuous(Years) | Pegilodecakin + Pembrolizumab | Pebrolizumab | Total |
|---|---|---|---|
| Mean | 67.5 ± 7.7 | 67.1 ± 9.0 | 67.3 ± 8.3 |
| Sex: Female, Male(Participants) | Pegilodecakin + Pembrolizumab | Pebrolizumab | Total |
|---|---|---|---|
| Female | 23 | 18 | 41 |
| Male | 28 | 32 | 60 |
| Ethnicity (NIH/OMB)(Participants) | Pegilodecakin + Pembrolizumab | Pebrolizumab | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 40 | 47 | 87 |
| Unknown or Not Reported | 8 | 1 | 9 |
| Race (NIH/OMB)(Participants) | Pegilodecakin + Pembrolizumab | Pebrolizumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 39 | 38 | 77 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(Participants) | Pegilodecakin + Pembrolizumab | Pebrolizumab | Total |
|---|---|---|---|
| United States | 51 | 50 | 101 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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 European Union (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 Dec 2019, 20 months.
Results were first posted in Jan 2021, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 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 →