Tislelizumab →surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesChemoradiotherapy
Tislelizumab: Compared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines: surgery if resectable after neoadjuvant treatment
Chemoradiotherapy: if patient not resectable after neoadjuvant treatment, chemoradiotherapy performed
Study summary
A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC.
Adults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
radical surgery (R0) in patients with stage III PD-L1 positive — 3 years 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.
Trial sites (1)
Facility
City
Region
Status
Istituti Fisioterapici Ospitalieri
Rome
Roma (RM)
Recruiting
More Fondazione Ricerca Traslazionale trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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