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NCT07501169PHASE2NOT_YET_RECRUITING

Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)

Sponsor: Sichuan University + Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Interventions
Sacituzumab Tirumotecan and Anlotinib
Enrollment
33 participants
Primary completion
Aug 2027
Study completion
Dec 2028
First posted
Mar 2026
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Objective Response Rate (ORR)

Time frame: 24 months

Secondary Endpoints

Progression Free Survival (PFS)

Overall Survival (OS)

Disease control response (DCR)

Eligibility Criteria

Inclusion Criteria: * 1.Voluntary participation with written informed consent obtained prior to any study-specific procedures. * 2.Age ≥ 18 years and ≤ 75 years, regardless of sex. * 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * 4.Life expectancy of at least 3 months. * 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry/immunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system. * 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1/L1 inhibitors; no more than two prior lines of therapy. Note: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose. * 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previousl

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov