Nivolumab in Combination With Chemotherapy, or Nivolumab in Combination With Ipilimumab, in Advanced EGFR-Mutant or ALK-Rearranged NSCLC
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT03256136
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Carboplatin — DRUGChemotherapy
- Nivolumab — DRUGwill allow the body's immune system to work against tumor cells
- pemetrexed — DRUGChemo therapy
- Ipilimumab — DRUGwill allow the body's immune system to work against tumor cells
Study Details
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
Key Dates
- Start date
- Nov 22, 2017
- Status verified
- Oct 2020
- Primary completion
- Aug 19, 2019
- Completion
- Aug 19, 2019
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab Plus Ipilimumab EGFRNivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks
- Experimental: Nivolumab Plus Ipilimumab ALKNivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks
- Experimental: Nivolumab + Carboplatin + Pemetrexed with EGFR Chemo naiveNivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks
- Experimental: Nivolumab + Carboplatin + Pemetrexed ALK Chemo naiveNivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks
Primary Outcome Measure
Objective Response Rate (ORR), Presented in Numbers of Participants [ Time Frame: Up to approximately 2 years ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Massachusetts general Hospital | Boston | Massachusetts | 02214 | - |
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