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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Non-Small Cell
• Intervention / Treatment: Drug: Tislelizumab; Drug: Pemetrexed Disodium; Drug: Carboplatin; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Feng Yao; Phone Number: 021-22200000-12345; Email: yaofeng@shsmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Principal Investigator: Feng Yao
      • Contact: Feng Yao; Phone Number: 021-22200000-12345; Email: xkyyGCP2021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
11. Patients of childbearing potential must be willing to use effective contraception during the study and for 120 days after the last dose of tislelizumab.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for enrollment:

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.).
11. Known history of human immunodeficiency virus (HIV) infection.
12. Previously undergone allogeneic stem cell transplantation or organ transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab plus platinum doublet chemotherapy	Drug: Tislelizumab; administered via Intravenous (IV) injection; Drug: Pemetrexed Disodium; administered via IV infusion; Drug: Carboplatin; administered via IV infusion; Drug: Cisplatin; administered via IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response (pCR) rate	Up to 3 months following completion of neoadjuvant treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to 3 years
Event-free survival (EFS)	Up to 3 years
Major pathological response (MPR) rate	Up to 3 months following completion of neoadjuvant treatment
Objective Response Rate (ORR)	Up to 3 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)	Up to 3 years

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 20, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Pemetrexed; Tislelizumab; Carboplatin
• Other Study ID Numbers: 2024IIT-145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No