Trial · NCT03631199
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
NCT03631199, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects. Trials, record NCT03631199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03631199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
- NCT number
- NCT03631199
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 673 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- canakinumab, canakinumab-matching placebo, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed
- First posted
- 2018-08-15
- Last updated
- 2026-06-17
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | During the first 42 days of dosing | A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol. |
| Primary | Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1 | 18 months | Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause. |
| Primary | Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 32 months | Overall survival is defined as the time from date of randomization to date of death due to any cause. |
| Secondary | Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 14 months | ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 14 months | Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. |
| Secondary | Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. |
| Secondary | Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 25 months | Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | During the first 42 days of dosing | The dose-determining set (DDS) included all participants from the safety set who met the minimum exposure criterion and had sufficient safety evaluations, or experienced a dose-limiting toxicity (DLT) during the first 42 days (6 weeks) of dosing. Data are reported for Part 1 only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1 | 18 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only. | months | MEDIAN |
| PRIMARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 32 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only. | months | MEDIAN |
| SECONDARY | Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 14 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only. | percentage of participants | NUMBER |
| SECONDARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only. | percentage of participants | NUMBER |
| SECONDARY | Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 14 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only. | percentage of participants | NUMBER |
| SECONDARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only. | percentage of participants | NUMBER |
| SECONDARY | Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 25 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Participants who never achieved a best overall response of CR or PR were excluded from the analysis. Data are reported for responders in Part 1 only. | months | MEDIAN |
| SECONDARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Participants who never achieved a best overall response of CR or PR were excluded from the analysis. Data are reported for responders in Part 2 only. | months | MEDIAN |
| SECONDARY | Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1 | Up to approximately 26 months | The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for responders in Part 2 only. | months | MEDIAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group510
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | Part 1: Cohort A | 0 | Participants | ||
| Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | Part 1: Cohort B | 0 | Participants | ||
| Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | Part 1: Cohort C | 1 | Participants | ||
| Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1 | Part 2: Canakinumab+Pembro+CTx | 6.77 | 95% Confidence Interval 5.62 to 7.75 | months | |
| Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1 | Part 2: Placebo+Pembro+CTx | 6.77 | 95% Confidence Interval 5.52 to 6.93 | months | |
| Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1 | Part 2: Canakinumab+Pembro+CTx | 20.83 | 95% Confidence Interval 16.26 to NA | months | |
| Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1 | Part 2: Placebo+Pembro+CTx | 20.17 | 95% Confidence Interval 16.23 to 22.37 | months | |
| Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Part 1: Cohort A | 20.0 | 95% Confidence Interval 2.5 to 55.6 | percentage of participants | |
| Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Part 1: Cohort B | 72.7 | 95% Confidence Interval 39.0 to 94.0 | percentage of participants | |
| Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | Part 1: Cohort C | 44.4 | 95% Confidence Interval 13.7 to 78.8 | percentage of participants |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Cohort A | 10 | |
| Overall Study | STARTED | Part 1: Cohort B | 11 | |
| Overall Study | STARTED | Part 1: Cohort C | 9 | |
| Overall Study | STARTED | Part 2: Canakinumab+Pembro+CTx | 320 | |
| Overall Study | STARTED | Part 2: Placebo+Pembro+CTx | 323 | |
| Overall Study | COMPLETED | Part 1: Cohort A | 0 | |
| Overall Study | COMPLETED | Part 1: Cohort B | 0 | |
| Overall Study | COMPLETED | Part 1: Cohort C | 0 | |
| Overall Study | COMPLETED | Part 2: Canakinumab+Pembro+CTx | 0 | |
| Overall Study | COMPLETED | Part 2: Placebo+Pembro+CTx | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events4,180
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 | Part 1: Cohort A (On-treatment) | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort B (On-treatment) | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort C (On-treatment) | 3 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Canakinumab+Pembro+CTx (On-treatment) | 153 | 320 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo+Pembro+CTx (On-treatment) | 148 | 322 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort A (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort B (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort C (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) | 0 |
1 to 10 of 4,180Source ClinicalTrials.gov
See all 4,180 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Cohort A (On-treatment) | 4 | 10 |
| Total, all-cause mortality | Part 1: Cohort B (On-treatment) | 1 | 11 |
| Total, all-cause mortality | Part 1: Cohort C (On-treatment) | 4 | 9 |
| Total, all-cause mortality | Part 2: Canakinumab+Pembro+CTx (On-treatment) | 97 | 320 |
| Total, all-cause mortality | Part 2: Placebo+Pembro+CTx (On-treatment) | 102 | 323 |
| Total, all-cause mortality | Part 1: Cohort A (Post-treatment Survival Follow-up) | 2 | 6 |
| Total, all-cause mortality | Part 1: Cohort B (Post-treatment Survival Follow-up) | 5 | 10 |
| Total, all-cause mortality | Part 1: Cohort C (Post-treatment Survival Follow-up) | 3 | 5 |
| Total, all-cause mortality | Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) | 50 | 223 |
| Total, all-cause mortality | Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) | 57 | 220 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38039427 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03631199
GET https://conductscience.org/api/trials/v1/NCT03631199/registered?page=2