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A Phase II Study of LOXO-292 in Patients With RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Primary Objective To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with LOXO-292 in patients with previously-treated Stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC). Secondary Objectives A key secondary objective is to evaluate the duration of BICR-assessed response among BICR responders. Additional secondary objectives are: To evaluate the frequency and severity of toxicities. To evaluate the investigator-assessed objective response rate (confirmed complete or partial response). To evaluate duration of investigator-assessed response among patients with a response as determined by the local investigator. To evaluate investigator-assessed progression-free survival (IA-PFS). To evaluate BICR-assessed PFS. To evaluate overall survival (OS). Among patients with brain metastases at baseline: To evaluate the central nervous system (CNS) response rate (confirmed CR). To evaluate the duration of intracranial response among patients with a CNS response. Translational Medicine Objectives To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA). Note: The translational medicine proposal to use these specimens will be submitted as a revision to CTEP for approval, prior to commencing next-generation sequencing (NGS) assays. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).



Recruitment Status

Past Studies