Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic NSCLC (INSIGHT)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 192

Inclusion Criteria

Phase Ib
a) Histologically or cytologically confirmed advanced NSCLC, regardless of histology subtype, which failed on gefitinib for reasons other than toxicity or compliance;
b) 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;
c) MET+ status, as determined by the central laboratory, i.e. c-Met overexpression as determined by immunohistochemistry (IHC) (i.e., IHC 2+ or IHC 3+);
d) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Phase II
a) Locally advanced or metastatic NSCLC other than predominantly squamous histology (confirmed by either histology or cytology);
b) Activating mutation of the EGFR receptor (documented, or as determined by the central laboratory);
c) Acquired resistance on first line EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib;
d) EGFR T790M status (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)
e) Availability of a fresh or archived tumor tissue (excluding fine needle aspiration and cytology samples) obtained between documentation of acquired resistance to EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib and enrollment is mandatory;
f) 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;
g) ECOG PS of 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

Exclusion Criteria (Phase Ib and Phase II)
a) Estimated life expectancy < 3 months;
b) Inadequate bone marrow, liver or renal functions;
c) 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 Ib only);
d) 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 II only).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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