Status:
NOT_YET_RECRUITING
A Phase II Study of QL1706 and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Lead Sponsor:
Zhijie Wang
Collaborating Sponsors:
Hebei Medical University Fourth Hospital
Peking University Cancer Hospital & Institute
Conditions:
SMARCA4-Deficient Tumor
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single-arm, open-label, Phase II study assesses first-line QL1706 (iparomlimab and tuvonralimab, an anti-PD-1/CTLA-4 bispecific antibody) combined with platinum-based chemotherapy to treat patien...
Detailed Description
SMARCA4-deficient non-small cell lung cancer (NSCLC) represents a highly aggressive molecular subtype, accounting for approximately 5-10% of all NSCLC cases. The majority of patients (over 80%) presen...
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria to be eligible for the study:
- Voluntary participation and provision of signed written informed consent.
- Age ≥ 18 years.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy.
- Tumor demonstrates loss of BRG1 protein (encoded by the SMARCA4 gene) as confirmed by immunohistochemistry (IHC).
- No prior systemic anti-cancer therapy for advanced disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willingness to provide archived or fresh tumor tissue samples from primary or metastatic lesions. If unavailable, enrollment may be permitted following investigator assessment.
- At least one measurable lesion as defined by RECIST v1.1.
- Adequate organ function within the screening period, as evidenced by:
- 1 Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L 10.2 Platelet count ≥ 100 × 10\^9/L 10.3 Hemoglobin ≥ 90 g/L (without transfusion within 14 days) 10.4 Serum creatinine ≤ 1 × ULN OR Creatinine clearance \> 50 mL/min (calculated by Cockcroft-Gault formula) 10.5 AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) 10.6 Total bilirubin ≤ 1.5 × ULN (except for participants with Gilbert's syndrome) 10.7 TSH, FT3, and FT4 within normal limits (±10%)
Exclusion
- Participants meeting any of the following criteria will be excluded from the study:
- Pathological diagnosis containing a small cell component.
- Symptomatic brain metastases.
- Leptomeningeal metastases.
- Recurrence within 6 months after completing prior adjuvant therapy (if applicable).
- Active, known, or suspected autoimmune disease (with specific exceptions, e.g., vitiligo, type I diabetes, hypothyroidism managed with hormone replacement only).
- Active tuberculosis (TB) infection or history of active TB within the past year.
- Comorbidities requiring immunosuppressive medications, including systemic corticosteroids at immunosuppressive doses.
- Pregnancy or lactation in female participants.
- Symptomatic interstitial lung disease that could interfere with the detection or management of suspected drug-related pulmonary toxicity.
- Known HIV infection, active Hepatitis B (HBsAg positive with HBV-DNA \> 10\^3 copies/mL), or active Hepatitis C (HCV antibody positive with detectable HCV-RNA).
- Significant history of neurological or psychiatric disorders.
- Treatment with any investigational drug within 4 weeks prior to the first dose of study treatment.
- Use of Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study treatment initiation.
- History of another active malignancy within the past 2 years (with specific exceptions for certain early-stage cancers).
- Significant cardiovascular or cerebrovascular disease history.
- Uncontrolled thrombotic events within 6 months prior to screening.
- Administration of a live vaccine within 28 days prior to the first study dose.
- Major surgery or significant trauma within 4 weeks prior to the first study dose.
- Conditions that may impair oral drug absorption.
- Uncontrolled active infection requiring systemic therapy.
- Known hypersensitivity to any of the study drug components.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07200947
Start Date
December 1 2025
End Date
February 1 2028
Last Update
October 1 2025
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China