Neoadjuvant chemo-immunotherapy for stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC)
Key facts
- Where
- Milan és Rome, OlaszországSee the 3 sites
- Phase
- 2. fázis
Where in Olaszország
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországTaking people
- San Raffaele HospitalMilan, OlaszországTaking people
- IFO-Regina Elena Institute for Cancer ResearchRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Ricerca Traslazionale
- Trial code
- EU 2024-519205-35-01
- Record updated
- 2026. szeptember 18.
- Original description
To evaluate the rate of radical surgery (R0) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatmentRead full original descriptionShow less
To evaluate the rate of radical surgery (R0) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment
Inclusion: Histologically confirmed stage III disease; Age ≥ 18 years; Written informed consent; PD-L1 TPS ≥ 1% according to local testing; No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing; Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent; Pulmonary function tests within 6 months of the planned resection; At least 1 measurable lesion as defined by RECIST v1.1; ECOG Performance Status ≤ 1; Eligibility to receive a platinum doublet chemotherapy regimen; Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug.
Exclusion: Any previous therapy for current lung cancer, including chemotherapy or radiation therapy; Concomitant participation in another therapeutic clinical trial; Evidence of stage IV NSCLC (metastatic disease); Active autoimmune diseases or history of autoimmune diseases that may recur; 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; Histology of large cell neuroendocrine carcinoma (LCNEC); Never smoking patients; Pregnancy or breastfeeding.