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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFondazione Ricerca Traslazionale

About this trial

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 criteria

Qualifiers

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.

Pulmonary function tests within 6 months of the planned resection.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tislelizumab
  • surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
  • Chemoradiotherapy

Treatment groups

30 Participants
are divided into 2 treatment groups