Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

NCT07129161 | Not Yet Recruiting Phase 2

• 1 other identifier: QL-NSCLC-QIBA-1003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) Rate

  Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of viable tumor cells in the resected lung tumor bed and lymph nodes.

  One week postoperatively

Secondary Outcomes (6)

• Major Pathologic Response (MPR) Rate

  One week postoperatively

• Objective Response Rate (ORR)

  Prior to surgery

• R0 Resection rate

  At time of surgery

• 2-Year Event-Free Survival (EFS) Rate

  up to 2 years

• Disease-free survival (DFS)

  up to 3 years

Study Arms (2)

Iparomlimab and Tuvonralimab combined with 2 cycles of chemotherapy as neoadjuvant therapy

EXPERIMENTAL

Iparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 2 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion.

Drug: 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy)

Iparomlimab and Tuvonralimab combined with 4 cycles of chemotherapy as neoadjuvant therapy

EXPERIMENTAL

Iparomlimab and Tuvonralimab (5mg/kg Q3W, for 4 cycles) combined with 4 cycles of platinum-based doublet chemotherapy will be administered as neoadjuvant therapy, followed by surgical resection within 6 weeks after completing neoadjuvant therapy. Postoperative adjuvant therapy with the Iparomlimab and Tuvonralimab (5mg/kg, Q3W) for up to 16 cycles may be administered at the investigator's discretion.

Drug: 4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)

Interventions

4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy) DRUG

Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w

Iparomlimab and Tuvonralimab combined with 2 cycles of chemotherapy as neoadjuvant therapy

4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy) DRUG

Iparomlimab and Tuvonralimab 5mg/kg：5mg/kg，q3W Platinum-based doublet chemotherapy：q3w

Iparomlimab and Tuvonralimab combined with 4 cycles of chemotherapy as neoadjuvant therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

The Second Affiliated Hospital of Air Force Medical University

Xi'an, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Junye Wang

CONTACT

13719229662; wangjy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 19, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (2)