Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02323126
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EGF816 — DRUG
    EGF816 150 mg once daily (QD) administered orally as a capsule
  • INC280 — DRUG
    INC280 400 mg twice daily (BID) administered orally as a tablet
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg every 2 weeks (Q2W) administered by intravenous infusion

Study Details

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

Key Dates

Start date
Feb 9, 2015
Status verified
Jan 2022
Primary completion
Sep 23, 2019
Completion
Feb 5, 2021

Study Design

Enrollment
64 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and EGF816
    Group 1: EGF816 150 mg QD + Nivolumab 3 mg/kg Q2W
  • Experimental: Nivolumab and INC280, high cMet
    Group 2A: INC280 400 mg BID, High cMET + Nivolumab 3 mg/kg Q2W
  • Experimental: Nivolumab and INC280, low cMet
    Group 2B: INC280 400 mg BID, Low cMet + Nivolumab 3 mg/kg Q2W

Primary Outcome Measure

Progression-Free Survival (PFS) Rate at 6 Months Per RECIST v1.1 [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)HoustonTexas77030-

Find similar trials in Houston, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)· Houston, TX

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