Trial · NCT03382899
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
NCT03382899, Phase 2, Terminated, Eli Lilly and Company; results first posted 2021-01-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer. Trials, record NCT03382899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03382899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT03382899
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Pegilodecakin, Pembrolizumab
- First posted
- 2017-12-26
- Last updated
- 2021-01-20
- Results first posted
- 2021-01-20
- Limitations and caveats
- Study was terminated early after completion of primary analysis; hence, no mature data were available for final analysis.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an Objective Response Rate (ORR) | From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months) | 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. |
| Secondary | Overall Survival (OS) | From Date of Randomization to Death Due to Any Cause (Up to 24 Months) | 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. |
| Secondary | Progression Free Survival (PFS) | From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months) | 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. |
| Secondary | Percentage of Participants Who Achieved a Disease Control Rate (DCR) | From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months) | 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. |
| Secondary | Duration of Response (DOR) | From Date of Response to Death Due to Any Cause (Up to 24 Months) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved an Objective Response Rate (ORR) | From Date of Randomization to Progressive Disease, Death from Any cause (Up to 24 Months) | All randomized participants who had adequate baseline and at least 1 post-baseline tumor assessments. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From Date of Randomization to Death Due to Any Cause (Up to 24 Months) | All randomized participants. Censored participants in the Pegilodecakin + Pembrolizumab arm is 32 and the Pembrolizumab arm is 39. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From Date of Randomization to Progressive Disease (PD) or Death Due to Any Cause (Up to 24 Months) | All randomized participants. Censored participants in the Pegilodecakin + Pembrolizumab arm is 24 and Pembrolizumab arm is 22. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Disease Control Rate (DCR) | From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 24 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From Date of Response to Death Due to Any Cause (Up to 24 Months) | All randomized participants. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an Objective Response Rate (ORR) | Pegilodecakin + Pembrolizumab | 47.1 | 95% Confidence Interval 32.9 to 61.5 | percentage of participants | |
| Percentage of Participants Who Achieved an Objective Response Rate (ORR) | Pembrolizumab | 44.0 | 95% Confidence Interval 30.0 to 58.8 | percentage of participants | |
| Overall Survival (OS) | Pegilodecakin + Pembrolizumab | 16.33 | 95% Confidence Interval 10.51 to NA | Months | |
| Overall Survival (OS) | Pembrolizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Pegilodecakin + Pembrolizumab | 6.28 | 95% Confidence Interval 2.86 to NA | Months | |
| Progression Free Survival (PFS) | Pembrolizumab | 6.08 | 95% Confidence Interval 2.23 to NA | Months | |
| Percentage of Participants Who Achieved a Disease Control Rate (DCR) | Pegilodecakin + Pembrolizumab | 62.7 | 95% Confidence Interval 48.1 to 75.9 | percentage of participants | |
| Percentage of Participants Who Achieved a Disease Control Rate (DCR) | Pembrolizumab | 62.0 | 95% Confidence Interval 47.2 to 75.4 | percentage of participants | |
| Duration of Response (DOR) | Pegilodecakin + Pembrolizumab | 14.23 | 95% Confidence Interval 2.50 to 14.23 | Months | |
| Duration of Response (DOR) | Pembrolizumab | NA | 95% Confidence Interval 4.14 to NA | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegilodecakin + Pembrolizumab | 51 | |
| Overall Study | STARTED | Pembrolizumab | 50 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pegilodecakin + Pembrolizumab | 50 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pembrolizumab | 48 | |
| Overall Study | COMPLETED | Pegilodecakin + Pembrolizumab | 20 | |
| Overall Study | COMPLETED | Pembrolizumab | 15 | |
| Overall Study | NOT COMPLETED | Pegilodecakin + Pembrolizumab | 31 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 35 |
Source ClinicalTrials.gov
Adverse events284
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pegilodecakin + Pembrolizumab | 30 | 50 | 92 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab | 10 | 48 | 18 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pegilodecakin + Pembrolizumab | 14 | 50 | 28 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab | 5 | 48 | 9 |
| other | Sinus tachycardia | Cardiac disorders | Pegilodecakin + Pembrolizumab | 4 | 50 | 4 |
| other | Sinus tachycardia | Cardiac disorders | Pembrolizumab | 1 | 48 | 1 |
| other | Tachycardia | Cardiac disorders | Pegilodecakin + Pembrolizumab | 4 | 50 | 4 |
| other | Tachycardia | Cardiac disorders | Pembrolizumab | 0 | 48 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pegilodecakin + Pembrolizumab | 1 | 50 | 2 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab | 3 | 48 | 3 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegilodecakin + Pembrolizumab | 19 | 50 |
| Total, all-cause mortality | Pembrolizumab | 13 | 48 |
| Total, other adverse events | Pegilodecakin + Pembrolizumab | 48 | 50 |
| Total, other adverse events | Pembrolizumab | 48 | 48 |
| Total, serious adverse events | Pegilodecakin + Pembrolizumab | 28 | 50 |
| Total, serious adverse events | Pembrolizumab | 25 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33166722 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pegilodecakin + Pembrolizumab vs Pembrolizumab: deaths from any cause | Trial comparisons |
| Pegilodecakin + Pembrolizumab vs Pembrolizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03382899
GET https://conductscience.org/api/trials/v1/NCT03382899/events?page=2