NRG-LU003

A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol

Principal Investigator

Jessica Jiyeong Lin

Status

Disease Site

Lung [LU] Non-small Cell Lung Cancer

Phase

II

Developmental Therapeutics

No

Primary Objective

• To assess whether ALK kinase domain mutations (G1202/C1156Y/I1171/L1196/ V1180/ F1174/ compound mutation) associated with drug resistance are prognostic for objective response to subsequent ALK inhibitor therapy.
• To assess whether subsequent pemetrexed based chemotherapy improves objective response comparing to ALK inhibitor therapy for no ALK mutation patients
• To evaluate objective responses of patients with specific genetic alterations (ALKL1198F/MET double mutation or high-level MET gene amplification) treated with crizotinib.

Patient Population

Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous NSCLC (includes M1a, M1b, M1c stage disease, AJCC 8^th edition). ALK rearrangement must have been demonstrated by an FDA approved assay (Vysis FISH or Ventana IHC) or by next generation sequencing (NGS). Patients must have progressive disease as defined by RECIST 1.1 after a second generation ALK inhibitor. The next generation ALK inhibitor must be the last ALK inhibitor given.

Target Accrual

660