TISLELIZUMAB for Non-small cell lung cancer (stage III) - PD-L1 positive

Inclusion criteria

• {"criterion_text":"- Histologically confirmed stage III disease."}
• {"criterion_text":"- Age ≥ 18 years."}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- PD-L1 TPS ≥ 1% according to local testing."}
• {"criterion_text":"- No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing."}
• {"criterion_text":"- Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent."}
• {"criterion_text":"- Pulmonary function tests within 6 months of the planned resection."}
• {"criterion_text":"- At least 1 measurable lesion as defined by RECIST v1.1."}
• {"criterion_text":"- ECOG Performance Status ≤ 1."}
• {"criterion_text":"- Eligibility to receive a platinum doublet chemotherapy regimen."}
• {"criterion_text":"- Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug"}

Exclusion criteria

• {"criterion_text":"- Evidence of stage IV NSCLC (metastatic disease)."}
• {"criterion_text":"- Histology of large cell neuroendocrine carcinoma (LCNEC)."}
• {"criterion_text":"- Any previous therapy for current lung cancer, including chemotherapy or radiation therapy"}
• {"criterion_text":"- Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1."}
• {"criterion_text":"- Never smoking patients."}
• {"criterion_text":"- Active autoimmune diseases or history of autoimmune diseases that may recur"}
• {"criterion_text":"- Concomitant participation in another therapeutic clinical trial."}
• {"criterion_text":"- Pregnancy or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.","definition_or_measurement_approach":"An R0 resection means that the surgical margin is microscopically negative for residual tumor."}

Secondary endpoints

• {"endpoint_text":"- Percentage of nodal downstaging defined as following neoadjuvant chemoimmunotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pathological complete response (pCR) and major pathological response (MPR). pCR means 0% residual viable tumor cells in the primary tumor and sampled lymph nodes; MPR means ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes.","definition_or_measurement_approach":"pCR means 0% residual viable tumor cells in the primary tumor and sampled lymph nodes; MPR means ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes."}
• {"endpoint_text":"- Event-free survival (EFS) was defined as the time from study enrollment to any progression of disease before local treatment (surgery or radiotherapy) or recurrence of disease after local treatment (surgery or radiotherapy), progression of disease in the absence of surgery, or death from any cause.","definition_or_measurement_approach":"EFS defined as time from enrollment to progression before local treatment, recurrence after local treatment, progression without surgery, or death from any cause."}
• {"endpoint_text":"- Overall survival (OS) was defined as the time from study enrollment to death of any cause","definition_or_measurement_approach":"OS defined as time from enrollment to death from any cause."}

Italy

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

10-09-2025

Processing Time Days

279

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Fondazione Ricerca Traslazionale

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy