Using tislelizumab and chemotherapy for lung cancer surgery

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

This study is testing if combining a new drug called tislelizumab with chemotherapy can help people with a specific type of lung cancer respond better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06659042 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of tislelizumab combined with platinum-based chemotherapy in patients with resectable stage II-IIIB (N2) KRAS-mutated nonsquamous non-small cell lung cancer. The primary goal is to assess the pathological complete response in participants undergoing this treatment regimen before surgical resection. Patients will receive treatment prior to surgery, and their responses will be closely monitored to determine the effectiveness of the approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed stage II-IIIB KRAS-mutated nonsquamous non-small cell lung cancer who are eligible for surgical resection.

Not a fit: Patients with non-resectable lung cancer or those without a KRAS mutation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival rates for patients with this specific type of lung cancer.

How similar studies have performed: While there have been studies exploring immunotherapy in lung cancer, this specific combination approach is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Feng Yao

Conditions Lung Cancer, Non-Small Cell