Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase 1

Completed

• Conditions: ocally advanced or Metastatic Non small Cell Lung Cancer (NSCLC)

• Registration Number: JPRN-jRCT2080223491
• Lead Sponsor: Merck KGaA,(for Japan) Merck Serono Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-24
• Results First Posted: 2020-07-23
• Study Completion: 2021-08-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Phase Ib
Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC), regardless of histology subtype, which failed on gefitinib for reasons other than toxicity or compliance
Availability of a fresh or archived pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples). For subjects who have had at least 1 prior anticancer treatment, a biopsy obtained between failure of the most recent anticancer treatment and enrollment is mandatory.
Mesenchymal-epithelial transition diagnostic-positive (status) (MET+ status), as determined by the central laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Other protocol defined inclusion criteria could apply.

Phase II
Locally advanced or metastatic NSCLC other than predominantly squamous histology (confirmed by either histology or cytology).
Activating mutation of the epidermal growth factor (EGFR) receptor (documented, or as determined by the central laboratory).
Acquired resistance on first line EGFR-Tyrosine Kinase Inhibitors(TKI)therapy including gefitinib, erlotinib, icotinib, or afatinib.
EGFR T790M status after acquired resistance to first line EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib treatment (as determined by the central laboratory, using a validated PCR test).
T790M negative status for the randomized part.
T790M positive status for the single-arm cohort (mainland China sites only).
Availability of a fresh or archived tumor tissue (excluding fine needle aspiration and cytology samples) obtained between documentation of acquired resistance to gefitinib, erlotinib, icotinib, or afatinib and enrollment is mandatory.
MET+ status, as determined by the central laboratory, i.e. c-Met overexpression as determined by IHC (i.e., IHC 2+ or IHC 3+) and/or c-Met amplification and/or increased c-Met gene copy number (GCN), both determined by ISH.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Other protocol defined inclusion criteria could apply

Exclusion Criteria

(Phase I and II):
Estimated life expectancy less than (<) 3 months.
Inadequate bone marrow, liver or renal functions.
Prior chemotherapy, biological therapy, radiation therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment (Phase 1b only).
Prior systemic anticancer treatment with chemotherapy or other agents targeting the EGFR pathway excluding gefitinib, erlotinib, icotinib, and afatinib for advanced NSCLC (one course of chemotherapy regimen for [neo] adjuvant purpose, or one course of chemoradiation for Stage IIIa disease is allowed) (Phase 2 only).
Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified