Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Lung Cancer, Non-Small Cell

In brief

The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.

Key facts

Study ID

NCT06659042

Run by

Shanghai Chest Hospital

People needed

32

Starts

2024-11-20

Expected to finish

2027-11-20

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.
• Male or female aged ≥18 years at the time of signing the ICF.
• Histologically or cytologically confirmed stage II-IIIB (N2) non-squamous non-small cell lung cancer (NSCLC) (AJCC 8th edition).
• With Known KRAS gene mutation.
• Evaluated by medical and surgical discussion to be eligible for R0 resection with curative intent prior to study enrollment.
• At least one measurable lesion as defined by RECIST v1.1.
• Eligible to receive platinum-based doublet chemotherapy.
• ECOG performance status score ≤ 1.
• Adequate organ function during the screening period
• Good cardiopulmonary function, meeting the requirements for surgical resection with curative intent.
• Patients of childbearing potential must be willing to use effective contraception during the study and for 120 days after the last dose of tislelizumab.

You may not qualify if…

• Patients meeting any of the following criteria are not eligible for enrollment:
• Previously received any treatment for the current lung cancer, including radiotherapy and all systemic anti-tumor treatments, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy.
• Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.
• Received other approved systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymosin α1, and thymalfasin) within 4 weeks prior to the first dose.
• Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.
• Received live or attenuated live vaccines within 4 weeks prior to enrollment or expected to require live or attenuated live vaccines during the study or within 5 months after the last dose of tislelizumab.
• Any condition requiring systemic corticosteroid therapy (prednisone or equivalent >10 mg/day) or other immunosuppressive therapy within 14 days prior to the first dose of the study drug, which the investigator believes may affect the study treatment.
• Active autoimmune disease requiring systemic treatment, which the investigator believes may affect the study treatment.
• Interstitial lung disease, non-infectious pneumonitis, or uncontrolled other diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., which the investigator believes may affect the study treatment.
• History of major diseases or clinical manifestations that may affect organ system function, which the investigator believes may affect the study treatment.
• Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to the first dose of the study drug (including tuberculosis infection, etc.).
• Known history of human immunodeficiency virus (HIV) infection.
• Previously undergone allogeneic stem cell transplantation or organ transplantation.

Where it is running

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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