Clinical trial · Interventional
Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
NCT07264647CI-TRIAL-00098400recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Radiation | — | UNRESOLVED |
| surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines | Procedure | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- surgery
- description
- After a neoadjuvant chemoimmuno treatment patient is selected to the surgery and immuno maintenance arm if resectable
- interventionNames
- Drug: Tislelizumab
- Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- type
- ACTIVE_COMPARATOR
- label
- chemoradio
- description
- After neoadjuvant chemoimmuno treatment patient is selected to surgery and immuno maintenance arm if resectable
- interventionNames
- Drug: Tislelizumab
- Radiation: Chemoradiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.