MK2870-004

Thoracic tumors
Non-small cell lung cancer (NSCLC)
Second line + Treatment (Metastatic Disease)
BRAF EGFR Exon 19-Mutation EGFR weitere Mutationen EGFR Exon 21-Mutation ROS1 RET Mutation
The MK-2870-004 trial is a randomized, open-label Phase III study comparing sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody-drug conjugate (ADC), with standard chemotherapy (docetaxel or pemetrexed) in adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring an EGFR mutation (exon 19 del or exon 21 L858R) or other genomic alterations (e.g., ALK rearrangements, ROS1 rearrangements, BRAF V600E, NTRK fusions, MET exon14 skipping, RET rearrangements or rare EGFR point mutations). The primary objectives are progression-free survival (PFS) per RECIST 1.1 assessed by blinded independent central review (BICR) and overall survival (OS). Inclusion criteria include documented radiographic progression, prior lines of EGFR TKI (for EGFR mutant cohort) and platinum-based therapy, measurable disease per RECIST 1.1, and ECOG performance status 0–1. Participants are randomized to either MK-2870 or chemotherapy. Key secondary endpoints include objective response rate (ORR) and duration of response (DOR).
This trial is evaluating whether the investigational drug sacituzumab tirumotecan (MK-2870) is more effective than standard chemotherapy (docetaxel or pemetrexed) in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have genetic alterations such as EGFR mutations or other genomic changes. The aim is to assess if MK-2870 can delay disease progression and improve overall survival. Eligible participants have non-squamous NSCLC that has been previously treated and now progressed. The molecular status (e.g., EGFR mutation or other genomic alterations) is confirmed at screening. Participants are randomized to receive either MK-2870 or chemotherapy. Key secondary objectives include evaluating response rate and duration of response.