2024-519205-35-01RecruitingPhase 2
Neoadjuvant chemo-immunotherapy for stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 8 Jul 2025
- Lead sponsor
- Fondazione Ricerca Traslazionale
- Diseases
- Lung cancer
- EU CT number
- 2024-519205-35-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous therapy for current lung cancer, including chemotherapy or radiation therapy
- Concomitant participation in another therapeutic clinical trial.
Other illness
- Evidence of stage IV NSCLC (metastatic disease).
- Active autoimmune diseases or history of autoimmune diseases that may recur
Lab values
- 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.
Other
- Histology of large cell neuroendocrine carcinoma (LCNEC).
- Never smoking patients.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
| San Raffaele Hospital | Milan | Italy | Recruiting |
| IFO-Regina Elena Institute for Cancer Research | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.