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 — DRUG
    Chemotherapy
  • Nivolumab — DRUG
    will allow the body's immune system to work against tumor cells
  • pemetrexed — DRUG
    Chemo therapy
  • Ipilimumab — DRUG
    will 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 EGFR
    Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks
  • Experimental: Nivolumab Plus Ipilimumab ALK
    Nivolumab administered intravenously every 2 weeks Ipilimumab administered intravenously every 6 weeks
  • Experimental: Nivolumab + Carboplatin + Pemetrexed with EGFR Chemo naive
    Nivolumab administered intravenously every 3 weeks Carboplatin administered intravenously every 3 weeks Pemetrexed administered intravenously every 3 weeks
  • Experimental: Nivolumab + Carboplatin + Pemetrexed ALK Chemo naive
    Nivolumab 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)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts general HospitalBostonMassachusetts02214-

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