Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)

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

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.

Conditions3

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