Perioperative iparomlimab and tuvonralimab with or without chemotherapy for resectable NSCLC

Perioperative Study of Iparomlimab and Tuvonralimab in Resectable NSCLC

This study will test whether giving the immunotherapy regimen QL1706 (iparomlimab and tuvonralimab) before and around the time of surgery, with or without platinum-based chemotherapy, helps people with resectable stage II–IIIB non-small cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: Iparomlimab, Tuvonralimab
• Locations: 1 site (Beijing)
• Trial ID: NCT06897046 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial enrolling adults with treatment‑naïve, resectable stage II–IIIB (N2 only) non‑small cell lung cancer to receive the immunotherapy regimen QL1706 either alone or combined with carboplatin plus paclitaxel (albumin‑bound) or pemetrexed in the perioperative setting. Patients will receive therapy before and/or after surgery as defined by the protocol, and tumor tissue and other biospecimens will be collected for biomarker analyses such as PD‑L1 and genetic sequencing. The study will monitor safety, tolerability, pathological tumor response, and surgical outcomes. Results will be used to determine whether this perioperative approach warrants further development.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with treatment‑naïve, resectable stage II–IIIB (N2 only) NSCLC, ECOG 0–1, judged resectable by a multidisciplinary team including a thoracic surgeon, and able to provide tumor tissue for biomarker testing.

Not a fit: Patients with unresectable disease, prior systemic treatment for this lung cancer, ECOG performance status >1, or T4 tumors due to invasion (not size) are unlikely to be eligible or benefit from this perioperative approach.

Why it matters

Potential benefit: If successful, the regimen could shrink tumors before surgery, improve surgical outcomes, and lower the risk of cancer recurrence.

How similar studies have performed: Perioperative and neoadjuvant trials using PD‑1/PD‑L1 inhibitors combined with chemotherapy have shown promising improvements in pathological response, so this approach builds on encouraging but still emerging evidence.

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.

Where this trial is running

Beijing

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Shugeng Gao, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Shugeng Gao, MD

Conditions: Non-small Cell Lung Cancer, II-IIIB