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Recruiting NCT06659042

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

Phase II Interventional Lung Cancer, Non-Small Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, Cisplatin, Carboplatin, Pemetrexed Disodium.
Who it may be relevant to
Registry conditions: Lung Cancer, Non-Small Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tislelizumab
    administered via Intravenous (IV) injection
  • Drug Cisplatin
    administered via IV infusion
  • Drug Carboplatin
    administered via IV infusion
  • Drug Pemetrexed Disodium
    administered via IV infusion

Primary outcome measures

  • Pathological complete response (pCR) rate [Time frame: Up to 3 months following completion of neoadjuvant treatment]
Secondary outcome measures (5)
  • Major pathological response (MPR) rate [Time frame: Up to 3 months following completion of neoadjuvant treatment]
  • Objective Response Rate (ORR) [Time frame: Up to 3 years]
  • Event-free survival (EFS) [Time frame: Up to 3 years]
  • Overall survival (OS) [Time frame: Up to 3 years]
  • Number of participants experiencing treatment-emergent adverse events (TEAEs) [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06659042 · 2024IIT-145

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗