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A Phase II Study of QL1706 and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Sponsor: Zhijie Wang
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 patients with treatment-naïve, locally advanced or metastatic, SMARCA4-deficient non-small cell lung cancer (NSCLC). The main questions it aims to answer are:Evaluate the efficacy and safety of this combination regimen in this specific patient population. Explore correlations between tumor molecular characteristics, the immune microenvironment, and treatment efficacy or toxicity. Participants must: Have histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic non-small cell lung cancer (NSCLC) with SMARCA4 deficiency. Be willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment. Have at least one measurable lesion per RECIST v1.1.
Official title: A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Platinum-based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2025-12-01
Completion Date
2028-02-01
Last Updated
2025-10-01
Healthy Volunteers
No
Interventions
QL1706, nab-paclitaxel, carboplatin
Participants will receive QL1706 (5 mg/kg, IV, day 1) in combination with nab-paclitaxel (260 mg/m², IV, day 1) and carboplatin (AUC=4-5, 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) every 21 days. Treatment will continue until disease progression, unacceptable toxicity, consent withdrawal, investigator decision, loss to follow-up, death, or meeting other protocol-defined criteria for discontinuation. The maximum duration of QL1706 treatment is 24 months, after which continuation will be at the investigator's discretion based on individual benefit-risk assessment.
Locations (1)
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China