Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors

Sponsor
Beijing Chest Hospital
Study ID
NCT06764368
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab + Apatinib — DRUG
    Induction Phase: Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the investigator) + Apatinib (250 mg, orally, once daily) in 3-week cycles (Q3W) for 4 to 6 cycles. Maintenance Phase: Adebrelimab (1200 mg, Day 1) + Apatinib (250 mg, orally, once daily) will be administered for 1 year or until one of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent by the subject, voluntary withdrawal from the study, or other protocol-specified reasons.

Study Details

This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors. This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.

Key Dates

Start date
Jan 1, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subtype 1/2/3

Primary Outcome Measure

12-month PFS rate (Progression-Free Survival rate) [ Time Frame: 12-month ]

Central Contacts

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