Not yet recruiting NCT07129161
Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy), 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy).
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC.
Interventions
- Drug 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy)
Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w - Drug 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)
Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w
Primary outcome measures
- Pathologic Complete Response (pCR) Rate [Time frame: One week postoperatively]
Secondary outcome measures (6)
- Major Pathologic Response (MPR) Rate [Time frame: One week postoperatively]
- Objective Response Rate (ORR) [Time frame: Prior to surgery]
- R0 Resection rate [Time frame: At time of surgery]
- 2-Year Event-Free Survival (EFS) Rate [Time frame: up to 2 years]
- Disease-free survival (DFS) [Time frame: up to 3 years]
- Overall Survival (OS) [Time frame: up to 3 years]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 9th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
- MDT assessment (including a thoracic surgeon) confirms resectability.
- Provision of tumor tissue for biomarker analysis (e.g., PD-L1 testing, gene sequencing).
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status 0 or 1.
Exclusion criteria
- Confirmed EGFR or ALK mutations.
- Other malignancies within 5 years (exceptions: adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical surgery, ductal carcinoma in situ post-radical surgery).
- Prior treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors, CTLA-4 inhibitors) or immunostimulatory antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or anti-tumor immune cell therapy.
- Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) within 2 weeks prior to enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- The Second Affiliated Hospital of Air Force Medical University — Xi'an
Identifiers
NCT: NCT07129161 · QL-NSCLC-QIBA-1003