Clinical trial · Interventional
A Phase II Study of QL1706 With Anti-angiogenesis Therapy and Chemotherapy in Extensive-stage Small Cell Lung Cancer.
A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Bevacizumab and Platinum-based Chemotherapy in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706 , bevacizumab, etoposide , cisplatin or carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- combined treatment group
- description
- 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.
- interventionNames
- Drug: QL1706 , bevacizumab, etoposide , cisplatin or carboplatin
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From enrollment to the end of monitoring at 2 years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (16)
- BACKGROUNDZhang W, Deng P, Kong T, Zhang B, Qian F, Dong Y, Chen Y, Chen L, Liu D, Zhang Y, Yang H, Han B. Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2). Lung Cancer. 2022 Nov;173:43-48. doi: 10.1016/j.lungcan.2022.09.003. Epub 2022 Sep 8. PMID 36116169
- BACKGROUNDReck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. PMID 27458307
- BACKGROUNDZhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1. PMID 37158938
- BACKGROUNDHong MMY, Maleki Vareki S. Addressing the Elephant in the Immunotherapy Room: Effector T-Cell Priming versus Depletion of Regulatory T-Cells by Anti-CTLA-4 Therapy. Cancers (Basel). 2022 Mar 20;14(6):1580. doi: 10.3390/cancers14061580. PMID 35326731
- BACKGROUNDCheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, Huang C, Wei S, Sun H, Li X, Yu Y, Lai J, Yang H, Fang H, Chen H, Zhang P, Gu K, Wang Q, Shi J, Yi T, Xu X, Ye X, Wang D, Xie C, Liu C, Zheng Y, Lin D, Zhuang W, Lu P, Yu G, Li J, Gu Y, Li B, Wu R, Jiang O, Wang Z, Wu G, Lin H, Zhong D, Xu Y, Shu Y, Wu D, Chen X, Wang J, Wang M, Yang R. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30(10):2967-2976. doi: 10.1038/s41591-024-03132-1. Epub 2024 Jul 11.