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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: INC280 single agent; Drug: erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02468661

2015-001241-84 (EudraCT Number)

CINC280B2201

Details and patient eligibility

About

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.

Full description

The decision was taken to halt study enrollment with Cohort #3 in Phase Ib. Therefore, activities for the planned Phase II 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 generation)
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

INC280 200mg BID + ERL 150mg QD

Experimental group

Description:

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

Treatment:

Drug: erlotinib

Drug: INC280 single agent

INC280 400mg BID + ERL 150mg QD

Experimental group

Description:

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

Treatment:

Drug: erlotinib

Drug: INC280 single agent