Trial · NCT02511184
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
NCT02511184, Phase 1, Terminated, Pfizer; results first posted 2019-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients. Trials, record NCT02511184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02511184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
- NCT number
- NCT02511184
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ALK-positive Advanced NSCLC
- Interventions
- Crizotinib, Pembrolizumab
- First posted
- 2015-07-29
- Last updated
- 2019-07-01
- Results first posted
- 2019-07-01
- Limitations and caveats
- Some of the pre-defined outcome measures could not be analyzed because of premature termination, which was based on low enrollment rate.
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) | 6 weeks | Dose-limiting toxicity (DLT) was defined as any of the following adverse events (AEs) occurring in the first 2 cycles of treatment (6 weeks) which were attributable to crizotinib, pembrolizumab or both: hematologic toxicities including Grade 4 neutropenia, febrile neutropenia, Grade greater than or equal to (\>=) 3 neutropenic infection, Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; non-hematologic toxicities including Grade \>=3 toxicities (non-laboratory), Grade \>=3 nausea, vomiting, or diarrhea despite maximal therapy, non-hematologic Grade \>=3 laboratory value if medical intervention was required to treat the participant or the abnormality led to hospitalization; inability to complete at least 80 percent of the first 2-cycle doses of crizotinib or both infusions of pembrolizumab within the DLT observation period due to treatment-related toxicity. Grade was based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version 4.03. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | 2 years | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Secondary | Objective Response Rate (ORR) | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-progressive disease (PD) or not evaluated, and no new lesions. For target lesions, CR: complete disappearance of all target lesions; PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be non-pathological in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. |
| Secondary | Duration of Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | Duration of Response (DR) was defined as the time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. |
| Secondary | Time to Tumor Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | Time to Tumor Response (TTR) was defined as the time from the first dose of crizotinib or pembrolizumab to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. |
| Secondary | Progression Free Survival | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | Progression Free Survival (PFS) was defined as the time from the first dose of crizotinib or pembrolizumab to the first documentation of objective tumor progression or death on-study due to any cause, whichever occurred first. For participants who did not have documented objective progression during the study or were alive at last contact, the date of last contact was used. |
| Secondary | 6-Month, 12-Month and 18-Month Progression Free Survival Probabilities | Month 6, Month 12, and Month 18 | PFS probabilities were defined as the probability of being alive and progression free at 6, 12 and 18 months after the date of first dose based on the Kaplan Meier estimate. |
| Secondary | Overall Survival | Day 1 to end of study (for about 2 years) | Overall Survival (OS) was defined as the time from the first dose of crizotinib or pembrolizumab to the date of death due to any cause. For participants who were alive at last contact, the date of last contact was used. |
| Secondary | 12-Month and 18-Month Overall Survival Probabilities | Month 12 and Month 18 | OS probabilities were defined as the probability of being alive at 12 and 18 months after the date of first dose based on the Kaplan Meier estimate. |
| Secondary | Number of Participants With Maximum Grade in Laboratory Hematology Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment | 2 years | Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Hematology test results were graded by NCI CTCAE version 4.03. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) | 6 weeks | DLT evaluable population included all participants enrolled in the Dose Finding Phase who received at least 1 dose of crizotinib or pembrolizumab, and either experienced DLT during the first 2 cycles, or completed the observation period for the first 2 cycles of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events | 2 years | The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all treated participants who had an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all participants who achieved complete response or partial response. | days | MEDIAN |
| SECONDARY | Time to Tumor Response | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all participants who achieved complete response or partial response. | days | MEDIAN |
| SECONDARY | Progression Free Survival | Baseline, Week 9 and every 6 weeks thereafter, for about 2 years | The analysis population included all treated participants who had an adequate baseline tumor assessment. | days | MEDIAN |
| SECONDARY | 6-Month, 12-Month and 18-Month Progression Free Survival Probabilities | Month 6, Month 12, and Month 18 | Data were not collected. | ||
| SECONDARY | Overall Survival | Day 1 to end of study (for about 2 years) | The analysis population included all treated participants who had an adequate baseline tumor assessment. | days | MEDIAN |
| SECONDARY | 12-Month and 18-Month Overall Survival Probabilities | Month 12 and Month 18 | Data were not collected. | ||
| SECONDARY | Number of Participants With Maximum Grade in Laboratory Hematology Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment | 2 years | The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group184
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | Crizotinib + Pembrolizumab | 2 | Participants | ||
| Number of Participants With Dose-limiting Toxicity (DLT) | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 2 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib + Pembrolizumab | All-causality AE | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | All-causality AE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib + Pembrolizumab | All-causality SAE | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | All-causality SAE | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib + Pembrolizumab | Crizotinib-related AE | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | Crizotinib-related AE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib + Pembrolizumab | Crizotinib-related SAE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | Crizotinib-related SAE | 0 | Participants |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib + Pembrolizumab | 2 | |
| Overall Study | STARTED | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 7 | |
| Overall Study | COMPLETED | Crizotinib + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 0 | |
| Overall Study | NOT COMPLETED | Crizotinib + Pembrolizumab | 2 | |
| Overall Study | NOT COMPLETED | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 7 |
Source ClinicalTrials.gov
Adverse events194
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 | Crizotinib + Pembrolizumab | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 1 | 7 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Crizotinib + Pembrolizumab | 0 | 2 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 1 | 7 | 2 |
| other | Acute myocardial infarction | Cardiac disorders | Crizotinib + Pembrolizumab | 1 | 2 | 1 |
| other | Acute myocardial infarction | Cardiac disorders | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 0 | 7 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Crizotinib + Pembrolizumab | 1 | 2 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 0 | 7 | 0 |
| other | Tachycardia | Cardiac disorders | Crizotinib + Pembrolizumab | 1 | 2 | 1 |
| other | Tachycardia | Cardiac disorders | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 0 | 7 | 0 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib + Pembrolizumab | 1 | 2 |
| Total, all-cause mortality | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 0 | 7 |
| Total, other adverse events | Crizotinib + Pembrolizumab | 2 | 2 |
| Total, other adverse events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 7 | 7 |
| Total, serious adverse events | Crizotinib + Pembrolizumab | 2 | 2 |
| Total, serious adverse events | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Crizotinib + Pembrolizumab vs Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab: Number of Participants With Dose-limiting Toxicity (DLT) | Trial comparisons |
| Crizotinib + Pembrolizumab vs Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab: deaths from any cause | Trial comparisons |
| Crizotinib + Pembrolizumab vs Crizotinib Monotherapy Followed by Crizotinib + 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/NCT02511184
GET https://conductscience.org/api/trials/v1/NCT02511184/registered?page=2