Neoadjuvant chemo-immunotherapy for PD-L1–positive Stage III non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, phase 2, monocentric trial giving three cycles of neoadjuvant chemo-immunotherapy tailored by tumor histology, followed by restaging with chest CT and PET-CT and pathologic lymph-node reassessment. Patients with nodal clearance after neoadjuvant therapy will be considered for surgery, while those with persistent N2/N3 disease will proceed to definitive concurrent chemoradiation per routine practice. After local therapy, all patients will receive one year of adjuvant or maintenance tislelizumab. Enrollment is limited to adults with PD-L1 TPS ≥1% and no actionable driver mutations, and baseline multidisciplinary staging including PET-CT and brain MRI is mandatory.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed stage III disease.

  * 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:

Patients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:

Absolute neutrophil count ≥ 1.5 x 109 /L Platelets ≥ 75 x 109 /L Hemoglobin ≥ 90 g/L Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9).

For patients intended to receive cisplatin: creatinine clearance 60mL/min For patients intended to receive carboplatin: creatinine clearance 45mL/min Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome).

AST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN

* Age ≥ 18 years.
* Written informed consent.

Exclusion Criteria:

Evidence of stage IV NSCLC (metastatic disease).

* Histology of large cell neuroendocrine carcinoma (LCNEC).
* Any previous therapy for current lung cancer, including chemotherapy or radiation therapy.
* 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.
* Never smoking patients.
* Active autoimmune diseases or history of autoimmune diseases that may recur.
* Concomitant participation in another therapeutic clinical trial.
* Pregnancy or breastfeeding.

Where it's running

• Istituti Fisioterapici Ospitalieri
  Rome, Roma (RM), Italy Recruiting

Study contacts

• Principal investigator: Federico Cappuzzo — Istituti Fisioterapici Ospitalieri
• Study coordinator: Federico Cappuzzo, Medical Oncology
• Email: federico.cappuzzo@fondazionefort.org
• Phone: +390652665789

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.