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Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Prospective, Single-arm Phase II Study of the Efficacy and Safety of Tislelizumab in Combination With Chemotherapy Perioperative Treatment for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

NCT06659042•Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. 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.
•2. Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.
•3. 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.
•4. Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.
•5. 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.
•6. 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.
•7. Active autoimmune disease requiring systemic treatment, which the investigator believes may affect the study treatment.
•8. 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.
•9. History of major diseases or clinical manifestations that may affect organ system function, which the investigator believes may affect the study treatment.
•10. 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.).
+2 more criteria

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 20, 2024

Primary Completion Date

November 20, 2025

Completion Date

November 20, 2027

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Cancer, Non-Small Cell

Interventions

Tislelizumab

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed Disodium

DRUG

Contacts

Feng Yao

CONTACT

021-22200000-12345 yaofeng@shsmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Engagement of Veterans With Lung Cancer

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

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