Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC

NCT ID: NCT06897046

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-05-25

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iparomlimab and Tuvonralimab combined chemotherapy neoadjuvant

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

PD-1/CTLA4 combined chemotherapy drugs

Iparomlimab and Tuvonralimab Neoadjuvant

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

Group Type: EXPERIMENTAL

QL1706

Intervention Type: DRUG

PD-1/CTLA-4

Interventions

QL1706

PD-1/CTLA-4

Intervention Type: DRUG

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

PD-1/CTLA4 combined chemotherapy drugs

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Voluntary Participation，willing to participate in this study and has signed the Informed Consent Form (ICF).

2. Age, ≥18 years old, both male and female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

4. 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.

5. The primary NSCLC is deemed resectable by multidisciplinary team (MDT) assessment, which must include a thoracic surgeon specializing in oncologic surgery.

6. 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.

7. At least one measurable lesion according to RECIST v1.1 criteria, as determined by the investigator.

Exclusion Criteria

• 1. 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.

3. 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.

4. History of Allogeneic Hematopoietic Stem Cell Transplantation or Solid Organ Transplantation: (except for corneal transplantation).

5. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shugeng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Jie Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanxi Province Cancer Hospital

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shugeng Gao, MD

Role: CONTACT

gaoshugeng@cicams.ac.cn

8610-87788177

Facility Contacts

Shugeng Gao

Role: primary

gaoshugeng@vip.sina.com

0086-13681130082

Role: backup

gaoshugeng@vip.sina.com

Other Identifiers

QL-NSCLC-QIBA-1001

Identifier Type: -

Identifier Source: org_study_id