Comparison · NCT02511184-dd3e2aa8
Crizotinib + Pembrolizumab vs Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab: Number of Participants With Dose-limiting Toxicity (DLT)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Crizotinib + Pembrolizumab vs Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab: Number of Participants With Dose-limiting Toxicity (DLT). Trial comparisons, record NCT02511184-dd3e2aa8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02511184-dd3e2aa8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 0.286 | 0.0822 | 0.641 | wilson | |
| Risk difference, group 1 minus group 2 | 0.714 | -0.0332 | 0.918 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.5 | 1.08 | 11.3 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Crizotinib + Pembrolizumab than on Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | 1.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Crizotinib + Pembrolizumab | Participants were administered combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first. | 2 | 2 | OG000 |
| Group 2 | Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab | Participants were administered monotherapy of crizotinib (250 mg capsule orally, twice daily) for 3 weeks, and if tolerated, followed by combination therapy of crizotinib (250 mg capsule orally, twice daily) and pembrolizumab (200 mg via 30-minute intravenous infusion, every 3 weeks) until disease progression and no clinical benefit, or unacceptable toxicity, death, or consent withdrawal, whichever occurred first. | 2 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Dose-limiting Toxicity (DLT)
- Description
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.
- Time frame
- 6 weeks
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
- NCT number
- NCT02511184
- Phases
- PHASE1
- Conditions
- ALK-positive Advanced NSCLC
- Interventions
- Crizotinib, Pembrolizumab
- Lead sponsor
- Pfizer
- Results first posted
- 2019-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02511184?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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