An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC

NCT07452003 | Recruiting

• 2 other identifiers: PUMCH-K8601L248072
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-arm phase II exploratory study evaluating a perioperative regimen of iparomlimab and tuvonralimab (QL1706; a bispecific PD-1/CTLA-4 antibody) combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage IIB-IIIB non-small cell lung cancer (NSCLC) without actionable driver alterations. Approximately 30 eligible participants will receive three 21-day cycles of neoadjuvant QL1706 plus chemotherapy, followed by surgical resection if feasible. After surgery, participants will be followed regularly to assess pathologic response, recurrence, survival outcomes, and safety, including immune-related adverse events. The primary efficacy endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor in the resected specimen. Secondary endpoints include event-free survival, overall survival, objective response rate, disease control rate, and R0 resection rate. Exploratory analyses will evaluate changes in the tumor immune microenvironment and peripheral immune profiles using tumor tissue and blood samples, including T-cell and B-cell receptor repertoire analyses and multi-omics profiling, with the goal of developing models to predict treatment benefit and immune-related toxicity risk.

Conditions

Non-Small Cell Lung Cancer

Keywords

Neoadjuvant immunotherapy; QL1706; Immune checkpoint inhibitor; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with major pathological response (MPR)

  MPR is defined as ≤10% residual viable tumor cells in the resected primary tumor specimen (and resected lymph nodes if applicable) assessed by histopathologic review after neoadjuvant therapy.

  Perioperative/Periprocedural (Day of surgery)

Secondary Outcomes (3)

• Percentage of participants with pathological complete response (pCR)

  Perioperative/Periprocedural (Day of surgery)

• Safety and Tolerability

  From first dose (Day 1) through 30 days after surgery

• Percentage of participants with R0 resection

  Perioperative/Periprocedural (Day of surgery)

Study Arms (1)

QL1706 Combination Therapy Arm

EXPERIMENTAL

Drug: QL1706 plus chemotherapy

Interventions

QL1706 plus chemotherapy DRUG

QL1706, a bispecific anti-PD-1/CTLA-4 monoclonal antibody, is administered intravenously in combination with standard platinum-based chemotherapy as neoadjuvant treatment prior to surgery. Treatment is given for a planned number of cycles before surgical resection.

QL1706 Combination Therapy Arm

Eligibility Criteria

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

You may not qualify if:

• The subject voluntarily participates in the study, provides written informed consent, demonstrates good compliance, and is willing to cooperate with study procedures and follow-up.
• Age ≥18 years at the time of signing the informed consent form; sex not restricted.
• Histologically confirmed non-small cell lung cancer (NSCLC).
• At least one measurable lesion according to RECIST version 1.1 (measurable lesion defined as a longest diameter ≥10 mm on spiral CT scan, or lymph node with a short axis ≥15 mm).
• No prior systemic therapy or local treatment for NSCLC.
• TNM stage IIB to IIIB disease, assessed by surgeons as resectable or potentially resectable.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Pulmonary function within normal limits.
• Adequate hematologic and organ function, based on laboratory tests obtained within 14 days prior to initiation of study treatment (unless otherwise specified):
• Hematology (no blood transfusion, G-CSF, or corrective medications within 14 days prior to screening):
• Hemoglobin ≥90 g/L
• Absolute neutrophil count ≥1.5 × 10⁹/L
• Platelet count ≥100 × 10⁹/L
• Biochemistry (no albumin infusion within 14 days prior to screening):
• ALT and AST ≤2.5 × upper limit of normal (ULN)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hanping Wang, MD, PhD

  Department of Pulmonary and Critical Care MedICIsne, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

binhe Tian

CONTACT

+8617782646786; 17782646786@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 5, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

CN (1)