A Phase II Study of QL1706 With Anti-angiogenesis Therapy and Chemotherapy in Extensive-stage Small Cell Lung Cancer.

Sponsor
Zhijie Wang
Study ID
NCT07083375
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extensive Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • QL1706 , bevacizumab, etoposide , cisplatin or carboplatin — DRUG
    Participants will receive QL1706 (5 mg/kg, IV, day 1), bevacizumab (7.5 mg/kg, IV, day 1), etoposide (100 mg/m², IV, days 1-3), plus either cisplatin (75 mg/m² split over days 1-2, IV) or carboplatin (AUC=5, IV, day 1) every 21 days for 4-6 cycles. Dose adjustments may be made based on clinical judgment. Patients who do not experience disease progression or intolerable toxicity will proceed to maintenance therapy with QL1706 (5 mg/kg, IV, day 1) and bevacizumab (7.5 mg/kg, IV, day 1) every 21 days, continued until disease progression, unacceptable toxicity, consent withdrawal, investigator decision, loss to follow-up, death, or other protocol-defined criteria. All participants will receive dual-agent maintenance therapy.

Study Details

This single-arm, open-label, Phase II study assesses first-line QL1706 + bevacizumab (anti-VEGF) + platinum/etoposide chemotherapy to treat naïve ES-SCLC patients.The main questions it aims to answer are: Evaluate efficacy and safety of this quadruplet regimen in ES-SCLC Explore correlations between tumor biomarkers and treatment efficacy Participants will: Histologically or cytologically confirmed, treatment-naïve extensive-stage small cell lung cancer (ES-SCLC). Willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment. At least one measurable lesion per RECIST v1.1

Key Dates

First listed
Jul 24, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: combined treatment group
    This study investigates a novel four-drug first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), combining QL1706-a bifunctional antibody targeting both PD-1 and CTLA-4-with bevacizumab (anti-VEGF) and platinum-based chemotherapy (etoposide + cisplatin or carboplatin). QL1706 is uniquely engineered to provide dual checkpoint inhibition with reduced CTLA-4 exposure, potentially enhancing efficacy while limiting immune-related toxicity. Bevacizumab adds antiangiogenic activity, aiming to improve immune infiltration and drug delivery. This synergistic approach integrates immunotherapy, antiangiogenesis, and cytotoxic agents to overcome resistance and extend survival. All patients receive dual-agent maintenance (QL1706 + bevacizumab) post-induction. No prior studies have evaluated this specific combination in ES-SCLC.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From enrollment to the end of monitoring at 2 years. ]

Central Contacts