Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 pre treatment tumor biopsy (excluding fine needle aspiration and cytology samples). For participants who have had at least 1 prior anticancer treatment, a biopsy obtained between failure of the most recent anticancer treatment and enrolment 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
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 (EGFR-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
You may not be if
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 study 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)
Clareo Health | Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)
