Starting soon
Phase 2
A Phase II Study of QL1706 With Anti-angiogenesis Therapy and Chemotherapy in Extensive-stage Small Cell Lung Cancer.
Condition(s) studied
Extensive Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
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.
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
Eligibility
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for the study:
1. Signed written informed consent and willingness to comply with study procedures.
2. Age ≥18 years.
3. Estimated life expectancy ≥3 months.
4. ECOG performance status of 0 or 1.
5. Histologically or cytologically confirmed, treatment-naïve extensive-stage small cell lung cancer (ES-SCLC).
6. Willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment.
7. At least one measurable lesion per RECIST v1.1.
8. Fully understands and voluntarily participates in the study.
9. Adequate organ function as defined below:
* Absolute neutrophil count ≥1.5 × 10⁹/L
* Platelets ≥100 × 10⁹/L
* Hemoglobin ≥90 g/L (without transfusion in prior 14 days)
* Serum creatinine ≤1× ULN or creatinine clearance \>50 mL/min (Cockcroft-Gault)
* AST and ALT ≤2.5× ULN (≤5× ULN with liver metastases)
* Total bilirubin ≤1.5× ULN (except Gilbert's syndrome \<51.3 µmol/L)
* TSH, FT3, FT4 within ±10% of normal limits
Exclusion Criteria:
1. Prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy.
2. Histologic or cytologic evidence of non-small cell or mixed small cell/non-small cell carcinoma.
3. Symptomatic brain metastases or leptomeningeal disease.
4. Active or suspected autoimmune disease, except for stable vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement, or conditions not expected to recur.
5. Evidence or history of active pulmonary tuberculosis (TB), including treated TB within the past year.
6. Concomitant condition requiring systemic corticosteroids or other immunosuppressive therapy.
7. Pregnant or breastfeeding females.
8. Symptomatic interstitial lung disease or suspected drug-related pneumonitis.
9. Positive for HIV antibodies, active HBV (HBsAg+ with HBV DNA \>10³ copies/mL), or active HCV infection (HCV-Ab+ with detectable RNA).
10. History of significant neurological or psychiatric disorders (e.g., dementia, depression, epilepsy, bipolar disorder).
11. Participation in another investigational drug study within 4 weeks prior to randomization.
12. Use of anti-tumor traditional Chinese medicine within 2 weeks prior to first study dose.
13. History of other malignancies within 2 years, except for cured non-melanoma skin cancers or certain in situ carcinomas.
14. Clinically significant cardiovascular or cerebrovascular disease (e.g., NYHA class ≥2 heart failure, recent myocardial infarction or stroke within 6 months).
15. History of thromboembolic events (e.g., DVT, PE, arterial thrombosis) within 6 months, except catheter-related thrombosis.
16. Live vaccination within 28 days before randomization or planned during the study.
17. Major surgery or significant trauma within 4 weeks prior to treatment initiation.
18. Conditions affecting drug absorption (e.g., severe vomiting, GI obstruction, active GI bleeding or perforation).
19. Active, uncontrolled bacterial, viral, or fungal infections despite appropriate treatment.
20. Known hypersensitivity to any study drug or excipients.
21. Any other condition deemed unsuitable by the investigator due to safety or compliance concerns.
Primary outcome measure(s)
- Progression-Free Survival (PFS) — From enrollment to the end of monitoring at 2 years.
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100021 |
Beijing |
Beijing Municipality |
|
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