Extract

Phase Ib  To determine the RP2D of tepotinib when used in combination with gefitinib (at the approved standard dose of 250 mg) when administered orally once daily over a 21-day cycle in subjects with MET+ advanced NSCLC. Phase II To evaluate whether the efficacy in terms of progression free survival (PFS) of second-line tepotinib in combination with gefitinib is superior to pemetrexed+cisplatin/carboplatin in subjects with T790M negative, MET+ locally advanced or metastatic NSCLC harboring an EGFR mutation and having acquired resistance to first-line EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib

Inclusion criteria

• Locally advanced or metastatic non-small cell lung cancer (NSCLC)

Links

• euctr
• euctr