Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: * Subjects must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging; * Squamous or non-squamous NSCLC histology; * Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion. * Subjects should be without EGFR exon 19 deletions or exon 21 L858R activating mutation; * Male and female, aged 18-75 years; * Blood and specimens before and after treatment must be provided; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; * Adequate renal functio…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source