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New treatment option for Lung Cancer, Non-Small Cell
Official title Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06659042
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer, non-small cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.