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

NCT07083375 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-24

No results posted yet for this study

Summary

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

Conditions

  • Extensive Small Cell Lung Cancer

Interventions

DRUG

QL1706 , bevacizumab, etoposide , cisplatin or carboplatin

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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Wuhan TongJi Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • Zhijie Wang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083375 on ClinicalTrials.gov