CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Carboplatin +3 moredrug
Likely dose
Nivolumab combined with carboplatin and pemetrexed, or nivolumab combined with ipilimumab (specific doses not stated in available intervention text)AI-extracted
Key inclusion· 8
  • ✓Advanced NSCLC (stage IIIB or IV) with EGFR activating mutation plus T790M, confirmed by local testing
  • ✓OR ALK-rearranged NSCLC with ALK rearrangement detected in >15% of tumor cells by FISH, IHC, or NGS
  • ✓Prior progression on one or more next-generation ALK-TKIs (for ALK-positive) OR third-generation T790M-selective EGFR-TKIs (for EGFR-mutant)
  • ✓For nivolumab/carboplatin/pemetrexed (cohorts A, B): no prior systemic chemotherapy allowed (prior adjuvant/neoadjuvant permitted if >12 months prior)
Key exclusion· 8
  • ✕Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1 agents
  • ✕Symptomatic brain metastases, carcinomatous meningitis, spinal cord compression, or intractable back pain from destructive mass
  • ✕Active, known, or suspected autoimmune disease (except type I diabetes, hypothyroidism requiring hormone replacement, or localized skin disorders not requiring systemic treatment)
  • ✕Systemic corticosteroids >10 mg daily prednisone equivalent or other immunosuppressive medications within 14 days of randomization (inhaled/topical steroids and adrenal replacement doses allowed)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03256136
NCT03256136Phase 2Completed
CompareCT.gov

A Phase II Study of Nivolumab in Combination With Carboplatin and Pemetrexed, or Nivolumab in Combination With Ipilimumab, in Patients With Advanced, EGFR-mutant or ALK-rearranged, Non-Small Cell Lung Cancer

Massachusetts General Hospital·interventional·Posted Aug 21, 2017·Updated Nov 4, 2020

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Nivolumab, and 2 other interventions for Lung Cancer. Completed, enrolled 9 participants across 3 sites.

Detailed Summary

This research study is studying a drug intervention as a possible treatment for lung cancer. The drugs involved in this study are: * Nivolumab * Carboplatin * Pemetrexed * Ipilimumab

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartNov 22, 2017
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.9 years ago

Interventions

Carboplatindrug

Chemotherapy

Nivolumabdrug

will allow the body's immune system to work against tumor cells

pemetrexeddrug

Chemo therapy

Ipilimumabdrug

will allow the body's immune system to work against tumor cells