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NCT07244926PHASE2NOT_YET_RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Lung Cancer
Interventions
Sacituzumab tirumotecan plus bevacizumab
Enrollment
31 participants
Primary completion
Jun 2027
Study completion
Jun 2028
First posted
Nov 2025
Last updated
Nov 2025

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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Source

Open on ClinicalTrials.gov