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
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.
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.
Single group
QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
DrugParticipants 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.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1.
Duration of Response (DoR)
DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who achieve CR, PR, or stable disease (SD) as their best overall response.
Immune-Related Adverse Events (irAEs)
Occurrence and grade of immune-related adverse events as defined by pre-specified criteria, including rash, colitis, hepatitis, endocrinopathies, and pneumonitis.
Biomarker Analysis
Tumor tissues were detected for PD-L1 using IHC. Potential biomarkers such as CD3+ and CD8+ were detected in peripheral blood.
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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
This trial is not recruiting at the moment. You can still explore other options:
