Sac-TMT Plus Bevacizumab as Second-Line Treatment for Advanced Non-Squamous Non-Small Cell Lung Cancer
Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in Second-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Without Actionable Gene Alterations: a Single-arm, Phase II Trial
Sponsor: Tianjin Medical University Cancer Institute and Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: up to approximately 60 months
Secondary Endpoints
Disease control response (DCR)
Duration of response (DOR)
Progression-free survival (PFS)
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old, regardless of gender * Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC (stage IIIB/C or IV not amenable to curative treatment) * Negative for EGFR sensitizing mutations \[no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)\] and ALK fusion gene, and no known actionable gene alterations in ROS1, NTRK, BRAF, MET, KRAS, HER2, or RET. * Disease progression after first-line platinum-based chemotherapy combined with anti-PD-(L)1 therapy. * At least one measurable lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to administration. * Expected life expectancy ≥ 12 weeks. * Adequate organ and bone marrow function. * Agreement to use effective medical contraception methods from the time of signing the informed consent form until 6 months after the last dose for female subjects of childbearing potential and male…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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