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

NCT07083375 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NCC5301
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

QL1706; Extensive Small Cell Lung Cancer; combination therapy; first line therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of monitoring at 2 years.

Secondary Outcomes (5)

• Overall Survival (OS)

  From enrollment to the end of monitoring at 2 years.

• Objective Response Rate (ORR)

  From enrollment to the end of monitoring at 2 years.

• Duration of Response (DoR)

  From enrollment to the end of monitoring at 2 years.

• Disease Control Rate (DCR)

  From enrollment to the end of monitoring at 2 years.

• The incidence of adverse events

  From enrollment to the end of monitoring at 2 years

Other Outcomes (2)

• Immune-Related Adverse Events (irAEs)

  From enrollment to the end of monitoring at 2 years

• Biomarker Analysis

  From enrollment to the end of monitoring at 2 years

Study Arms (1)

combined treatment group

EXPERIMENTAL

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.

Drug: QL1706 , bevacizumab, etoposide , cisplatin or carboplatin

Interventions

QL1706 , bevacizumab, etoposide , cisplatin or carboplatin DRUG

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.

combined treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• 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.
• 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.
• Fully understands and voluntarily participates in the study.
• 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)

You may not qualify if:

• 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.
• Evidence or history of active pulmonary tuberculosis (TB), including treated TB within the past year.
• Concomitant condition requiring systemic corticosteroids or other immunosuppressive therapy.
• Pregnant or breastfeeding females.
• Symptomatic interstitial lung disease or suspected drug-related pneumonitis.
• Positive for HIV antibodies, active HBV (HBsAg+ with HBV DNA \>10³ copies/mL), or active HCV infection (HCV-Ab+ with detectable RNA).
• History of significant neurological or psychiatric disorders (e.g., dementia, depression, epilepsy, bipolar disorder).
• Participation in another investigational drug study within 4 weeks prior to randomization.
• Use of anti-tumor traditional Chinese medicine within 2 weeks prior to first study dose.
• History of other malignancies within 2 years, except for cured non-melanoma skin cancers or certain in situ carcinomas.
• Clinically significant cardiovascular or cerebrovascular disease (e.g., NYHA class ≥2 heart failure, recent myocardial infarction or stroke within 6 months).
• History of thromboembolic events (e.g., DVT, PE, arterial thrombosis) within 6 months, except catheter-related thrombosis.

Sponsors & Collaborators

• Zhijie Wang: lead
• 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

Study Sites (1)

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, 100021, China

Location

Related Publications (16)

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MeSH Terms

Interventions

Bevacizumab; Etoposide; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Central Study Contacts

Zhijie Wang, MD

CONTACT

+86 13466323860; jie_969@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)