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

Status:	Recruiting
Conditions:	Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/12/2019
Start Date:	September 23, 2015
End Date:	March 31, 2020
Contact:	Novartis Pharmaceuticals
Email:	novartis.email@novartis.com
Phone:	1-888-669-6682

A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)

The purpose of this study is 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.

The decision was taken to halt study enrollment with Cohort #3 in Phase 1b. Therefore,
activities for the planned Phase 2 were not initiated.

This decision to stop further development of this combination was taken due to the challenge
for enrollment in this very rare patient population along with the rapidly evolving disease
landscape setting.

Inclusion Criteria:

- Locally advanced or metastatic NSCLC

- EGFR mutation (L858R and /or ex19del)

- cMET amplification by FISH (GCN ≥ 6),

- Acquired resistance to EGFR TKI (1st or 2nd génération)

- ECOG performance status (PS) ≤ 1.

Exclusion Criteria:

- Prior treatment with 3rd generation TKI

- PhaseII : Prior treatment with any of the following agents:

- Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.

- Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.

- Platinum-based chemotherapy as first line treatment

We found this trial at

sites

Virginia Cancer Specialists, PC Virginia Cancer Specialists

Fairfax, Virginia 22031

Principal Investigator: Alexander Spira

from

Fairfax, VA