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Trial Title:
Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
NCT ID:
NCT06659042
Condition:
Lung Cancer, Non-Small Cell
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
administered via Intravenous (IV) injection
Arm group label:
Tislelizumab plus platinum doublet chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
administered via IV infusion
Arm group label:
Tislelizumab plus platinum doublet chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
administered via IV infusion
Arm group label:
Tislelizumab plus platinum doublet chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed Disodium
Description:
administered via IV infusion
Arm group label:
Tislelizumab plus platinum doublet chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Feng Yao
Phone:
021-22200000-12345
Email:
xkyyGCP2021@163.com
Contact backup:
Last name:
Feng Yao
Start date:
November 20, 2024
Completion date:
November 20, 2027
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06659042
