MedTrace Logo

Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer

NCT07538193 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-20

No results posted yet for this study

Summary

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\<sub\>any\</sub\>N2b disease with mediastinal nodal status confirmed by EBUS/EUS or mediastinoscopy, and the determination by multidisciplinary team (MDT) assessment that the tumor is completely resectable (R0). Key exclusion criteria include known EGFR or ALK positive mutations, prior anti-cancer therapy for current lung cancer, active autoimmune disease, or uncontrolled hepatitis B or C.

Study Endpoints: The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), impact on surgical outcomes, and safety. Exploratory endpoints involve biomarker analysis including ctDNA.

Sample Size Rationale: Assuming a null hypothesis pCR rate (P0) of 8.8% (based on historical data) and an expected pCR rate (P1) of 28%, with a two-sided α of 5% and 80% power, 24 patients are required. Factoring in a 15% inoperable rate, the total sample size is 28 patients.

Statistical Analysis: The primary endpoint, pCR rate, and other binary endpoints will be summarized with frequencies, percentages, and their 95% confidence intervals calculated using the Clopper-Pearson method. Time-to-event endpoints (EFS, OS) will be analyzed using the Kaplan-Meier method. Safety data will be summarized descriptively.

Clinical Trial Information: This study is sponsored by The Second Affiliated Hospital of Air Force Medical University, PLA. The Principal Investigator is Dr. Yan Xiaolong.

Conditions

  • Carcinoma, Non-Small-Cell Lung (NSCLC)
  • Neoplasm Staging
  • Lymphatic Metastasis

Interventions

DRUG

Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)

Participants receive neoadjuvant treatment with Iparomlimab and Tuvonralimab in combination with platinum-based chemotherapy for three cycles prior to surgical resection. Dosing Regimen: For Non-squamous Carcinoma: Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Pemetrexed: 500 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles For Squamous Carcinoma: Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Nab-paclitaxel: 260 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles After completion of neoadjuvant therapy, participants undergo surgical resection within 6 weeks. Adjuvant treatment following surgery is administered at the discretion of the investigator and is not specified by this protocol.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-05-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538193 on ClinicalTrials.gov