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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).
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