About this trial
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
Eligibility criteria
Qualifiers
Signed written informed consent and willingness to comply with study procedures.
Age ≥18 years.
Estimated life expectancy ≥3 months.
ECOG performance status of 0 or 1.
Disqualifiers
Prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy.
Histologic or cytologic evidence of non-small cell or mixed small cell/non-small cell carcinoma.
Symptomatic brain metastases or leptomeningeal disease.
Active or suspected autoimmune disease, except for stable vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement, or conditions not expected to recur.
Trial design
Treatments tested in this trial
- QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
Treatment groups
Sponsors and collaborators
Zhijie Wang
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Peking University Cancer Hospital & Institute
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Wuhan TongJi Hospital
Collaborator
Peking University People's Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator