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NCT07193160PHASE2NOT_YET_RECRUITING

Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

A Multicenter, Single-arm, Phase II Clinical Study of Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

Sponsor: Fudan University

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
NSCLC (Non-small Cell Lung Cancer)
Interventions
Sacituzumab Tirumotecan, Furmonertinib
Enrollment
45 participants
Primary completion
Jul 2026
Study completion
May 2027
First posted
Sep 2025
Last updated
Sep 2025

Primary Endpoints (CT.gov)

Objective Response Rate (ORR)

Time frame: Up to approximately 12 months

Secondary Endpoints

Progression Free Survival (PFS)

Duration of Response (DoR)

Disease Control Rate (DCR)

Eligibility Criteria

Inclusion Criteria: * 1\. Aged 18 to 75 years at the time of signing the informed consent form, regardless of gender; 2. Histologically or cytologically confirmed non-squamous NSCLC, which is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) NSCLC that is not suitable for radical surgery and/or radical radiotherapy (whether concurrent chemotherapy is administered or not) \[according to the 8th Edition of the Lung Cancer TNM Staging System by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC)\]; 3. There must be medical records showing evidence of previous EGFR mutation test results (known presence of EGFR mutations sensitive to EGFR-TKI \[Ex19del, L858R\], which may exist alone or concurrently with other EGFR mutations, possibly including T790M); 4. Subjects who experienced extracranial radiological progression after achieving remission (CR or PR) or stable disease (SD ≥ 6 months) during the first-line treatment with third-generati

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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