A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02468661
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • INC280 single agent — DRUG
  • erlotinib — DRUG

Study Details

The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

Key Dates

First listed
Jun 11, 2015
Start date
Sep 23, 2015
Status verified
Feb 2020
Primary completion
Nov 15, 2017
Completion
Dec 5, 2018

Study Design

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

Arms

  • Experimental: INC280 200mg BID + ERL 150mg QD
    Subjects who took INC280 200mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)
  • Experimental: INC280 400mg BID + ERL 150mg QD
    Subjects who took INC280 400mg twice a day (BID) in combination with erlotinib (ERL) 150mg one a day (QD)

Primary Outcome Measure

Phase Ib: Frequency and characteristics of Dose Limiting Toxicity (DLTs) to the INC280 and erlotinib combination [ Time Frame: First 28 days of dosing ]

Locations (5)

FacilityCityStateZIPSite coordinators
Los Angeles Hematology/Oncology Medical GroupLos AngelesCalifornia90017-
University of California Irvine Medical Center Chao Family SCOrangeCalifornia92868-
Henry Ford Hospital SCDetroitMichigan48202-2689-
Dartmouth Hitchcock Medical Center SCLebanonNew Hampshire03756-
Seattle Cancer Care AllianceSeattleWashington98105-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Los Angeles Hematology/Oncology Medical Group· Los Angeles, CAUniversity of California Irvine Medical Center Chao Family SC· Orange, CAHenry Ford Hospital SC· Detroit, MIDartmouth Hitchcock Medical Center SC· Lebanon, NHSeattle Cancer Care Alliance· Seattle, WA

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