Trial · NCT03382912
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
NCT03382912, Phase 2, Terminated, Eli Lilly and Company; results first posted 2020-09-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer. Trials, record NCT03382912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03382912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
- NCT number
- NCT03382912
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Pegilodecakin, Nivolumab
- First posted
- 2017-12-26
- Last updated
- 2020-09-11
- Results first posted
- 2020-09-11
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 With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized) | 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. |
| Secondary | Overall Survival (OS) | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) | 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. |
| Secondary | Progression Free Survival (PFS) | From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized) | 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. |
| Secondary | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization) | 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. |
| Secondary | Duration of Response | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) | 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. |
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 With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized) | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) | All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 6 and Nivolumab = 5. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized) | All randomized participants. Participants censored: Pegilodecakin + Nivolumab = 12 and Nivolumab = 16. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization) | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized) | All randomized participants who received at least one dose of study drug and had CR or PR responses. Participants censored: Pegilodecakin + Nivolumab = 3 and Nivolumab = 1. | 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 With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Pegilodecakin + Nivolumab | 14.8 | 95% Confidence Interval 4.2 to 33.7 | Percentage of participants | |
| Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Nivolumab | 12.0 | 95% Confidence Interval 2.6 to 31.2 | Percentage of participants | |
| Overall Survival (OS) | Pegilodecakin + Nivolumab | 1.87 | 95% Confidence Interval 1.51 to 3.58 | Months | |
| Overall Survival (OS) | Nivolumab | 1.94 | 95% Confidence Interval 1.71 to 2.17 | Months | |
| Progression Free Survival (PFS) | Pegilodecakin + Nivolumab | 6.70 | 95% Confidence Interval 3.09 to NA | Months | |
| Progression Free Survival (PFS) | Nivolumab | 10.74 | 95% Confidence Interval 4.21 to NA | Months | |
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Pegilodecakin + Nivolumab | 37.0 | 95% Confidence Interval 19.4 to 57.6 | Percentage of participants | |
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Nivolumab | 28.0 | 95% Confidence Interval 12.1 to 49.4 | Percentage of participants | |
| Duration of Response | Pegilodecakin + Nivolumab | NA | 95% Confidence Interval 7.36 to NA | Months | |
| Duration of Response | Nivolumab | 3.06 | 95% Confidence Interval 1.87 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+Nivolumab | 27 | |
| Overall Study | STARTED | Nivolumab | 25 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pegilodecakin+Nivolumab | 27 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Nivolumab | 24 | |
| Overall Study | COMPLETED | Pegilodecakin+Nivolumab | 21 | |
| Overall Study | COMPLETED | Nivolumab | 13 | |
| Overall Study | NOT COMPLETED | Pegilodecakin+Nivolumab | 6 | |
| Overall Study | NOT COMPLETED | Nivolumab | 12 |
Source ClinicalTrials.gov
Adverse events218
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 + Nivolumab | 14 | 27 | 37 |
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab | 5 | 24 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pegilodecakin + Nivolumab | 5 | 27 | 15 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivolumab | 2 | 24 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Pegilodecakin + Nivolumab | 1 | 27 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Nivolumab | 4 | 24 | 5 |
| other | Ear discomfort | Ear and labyrinth disorders | Pegilodecakin + Nivolumab | 0 | 27 | 0 |
| other | Ear discomfort | Ear and labyrinth disorders | Nivolumab | 2 | 24 | 2 |
| other | Hypothyroidism | Endocrine disorders | Pegilodecakin + Nivolumab | 3 | 27 | 3 |
| other | Hypothyroidism | Endocrine disorders | Nivolumab | 3 | 24 | 3 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegilodecakin + Nivolumab | 15 | 27 |
| Total, all-cause mortality | Nivolumab | 12 | 24 |
| Total, other adverse events | Pegilodecakin + Nivolumab | 27 | 27 |
| Total, other adverse events | Nivolumab | 22 | 24 |
| Total, serious adverse events | Pegilodecakin + Nivolumab | 13 | 27 |
| Total, serious adverse events | Nivolumab | 9 | 24 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 + Nivolumab vs Nivolumab: deaths from any cause | Trial comparisons |
| Pegilodecakin + Nivolumab vs Nivolumab: 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/NCT03382912
GET https://conductscience.org/api/trials/v1/NCT03382912/events?page=2