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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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyRecruiting
San Raffaele HospitalMilanItalyRecruiting
IFO-Regina Elena Institute for Cancer ResearchRomeItalyRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.