Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov has registered a Phase II single-arm study (NCT07538193) evaluating iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy as neoadjuvant treatment for resectable stage III-N2b non-small cell lung cancer. The study will enroll 28 patients across approximately 4 centers in China, with an anticipated completion date of April 20, 2026.
“Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity.”
Sponsors conducting Applicable Clinical Trials (ACTs) under FDAAA 801 remain subject to registration and results reporting requirements on ClinicalTrials.gov. This trial's April 2026 target completion in China represents ongoing competitive activity in the PD-1/CTLA-4 bispecific antibody space for neoadjuvant lung cancer.
What changed
NIH ClinicalTrials.gov posted a clinical trial registration for a Phase II study of iparomlimab and tuvonralimab (QL1706), a novel bifunctional antibody targeting PD-1 and CTLA-4, in combination with platinum-based chemotherapy as neoadjuvant therapy for stage III-N2b non-small cell lung cancer.
Clinical investigators, oncology researchers, and pharmaceutical companies conducting applicable clinical trials should note this study as part of the competitive landscape for immuno-oncology combination therapies targeting PD-1 and CTLA-4 pathways in resectable lung cancer.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer
N/A NCT07538193 Kind: NA Apr 20, 2026
Abstract
Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity.
Objective: This phase II, single-arm, multicenter study aims to evaluate the efficacy and safety of neoadjuvant iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy in patients with resectable stage III-N2b NSCLC.
Study Design and Methods: A total of 28 patients will be enrolled across approximately 4 centers in China. Eligible patients (aged ≥18 years, ECOG PS 0-1) with histologically or cytologically confirmed, resectable stage III-N2b NSCLC (AJCC 9th edition) will receive three cycles of neoadjuvant therapy every three weeks. Patients with non-squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus pemetrexed (500 mg/m²) and carboplatin (AUC 5). Patients with squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus nab-paclitaxel (260 mg/m²) and carboplatin (AUC 5). Surgical resection will be performed within 6 weeks following completion of neoadjuvant therapy. Subsequent adjuvant treatment is at the discretion of the investigator.
Key Eligibility Criteria: Key inclusion criteria include pathologically confirmed T\any\N2b disease with mediastinal nodal status confi...
Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC), Neoplasm Staging, Lymphatic Metastasis
Interventions: Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)
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