Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC

NCT06897046 | Recruiting Phase 2 DMC

• 1 other identifier: QL-NSCLC-QIBA-1001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to study the efficacy and safety of Iparomlimab and Tuvonralimab with or without chemotherapyin the perioperative treatment of NSCLC

Conditions

Non-small Cell Lung Cancer (NSCLC); II-IIIB

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR)

  pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells

  4 weeks after surgery

Secondary Outcomes (4)

• Major Pathological Response Rate (MPR)

  4 weeks after surgery

• Objective Response Rate (ORR)

  After completion of neoadjuvant therapy, before surgery

• R0 Resection Rate

  2 weeks after surgery

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

  up to 2 years

Study Arms (2)

Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant

EXPERIMENTAL

Neoadjuvant: Squamous Non-Small Cell Lung Cancer, Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Paclitaxel（Albumin-bound ） 130 mg/m² Q3W (Day 1, Day 8) + Carboplatin (AUC=5) Q3W (Day 1) ; Non-Squamous Non-Small Cell Lung Cancer :Iparomlimab and Tuvonralimab 5 mg/kg Q3W (Day 1) + Pemetrexed 500 mg/m² Q3W (Day 1) + Carboplatin (AUC=5) Q3W (Day 1) Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options

Drug: QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed

Iparomlimab and Tuvonralimab Neoadjuvant

EXPERIMENTAL

Neoadjuvant: Prior to surgery, participants receive 2-4 cycles Iparomlimab and Tuvonralimab, 5 mg/kg Q3W (Day 1). Postoperative adjuvant therapy: Iparomlimab and Tuvonralimab combined chemotherapy or Iparomlimab and Tuvonralimab monotherapy or Other adjuvant treatment options

Drug: QL1706

Interventions

QL1706 DRUG

PD-1/CTLA-4

Iparomlimab and Tuvonralimab Neoadjuvant

QL1706+Carboplatin+Paclitaxel（Albumin-bound ）/ Pemetrexed DRUG

PD-1/CTLA4 combined chemotherapy drugs

Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant

Eligibility Criteria

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

You may qualify if:

• \. Voluntary Participation，willing to participate in this study and has signed the Informed Consent Form (ICF).
• \. Age, ≥18 years old, both male and female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• \. Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 8th 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.
• \. The primary NSCLC is deemed resectable by multidisciplinary team (MDT) assessment, which must include a thoracic surgeon specializing in oncologic surgery.
• \. Ability to provide surgical or biopsy tumor tissue for biomarker analysis (e.g., genetic sequencing, PD-L1 testing). The following must be provided before enrollment: Formalin-fixed paraffin-embedded (FFPE) tissue block from within the past 3 months, or 5-10 unstained tissue slides, or 2 core biopsy specimens, along with the relevant pathology report. Fine-needle aspiration specimens are not acceptable.
• \. At least one measurable lesion according to RECIST v1.1 criteria, as determined by the investigator.

You may not qualify if:

• \. Presence of confirmed EGFR or ALK positive mutations. 2. History of other malignancies within the past 5 years or concurrent malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
• \. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 agents), other drugs targeting T-cell receptors (e.g., CTLA-4), immune checkpoint agonist antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40 antibodies), or anti-tumor immune cell therapy.
• \. History of Allogeneic Hematopoietic Stem Cell Transplantation or Solid Organ Transplantation: (except for corneal transplantation).
• \. Presence of congenital or acquired immunodeficiency (e.g., HIV infection). 6. History of severe allergic reactions to other monoclonal antibodies. 7. As determined by the investigator, any other factors that may affect study outcomes or lead to premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric conditions) requiring concomitant treatment, significant laboratory abnormalities, or social or family factors that may impact patient safety.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

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)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Shugeng Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jie Wang, MD

  Shanxi Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shugeng Gao, MD

CONTACT

8610-87788177; gaoshugeng@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)