This pilot clinical trial studies how well local therapy (including surgical removal, ablation [using heat to destroy the tumor], or radiation therapy) and erlotinib hydrochloride work in treating patients with non-small cell lung cancer that has spread to more than one place in the body (oligometastatic) but less than five, and that has a mutation in the EGFR gene. Local therapy may help destroy the cancer in the places it has spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking the EGFR protein, which may help stop cancer cell growth. Using local therapy in combination with erlotinib hydrochloride may be a better treatment for oligometastatic, EGFR-mutant lung cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT02450591.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of local treatment of oligometastatic disease combined with TKI therapy.
II. To determine the feasibility of accruing eligible patients to undergo the proposed treatment plan.
III. To collect preliminary data on the efficacy of the proposed treatment strategy: time to progression, time to death, local control at site of local therapy, and time on EGFR TKI before a new systemic therapy is required.
SECONDARY OBJECTIVES:
I. To compare the molecular alterations in the primary lung versus metastatic sites by performing next-generation sequencing (IMPACT) on archived pre-treatment and resected specimens.
II. To evaluate cell free plasma deoxyribonucleic acid (cfDNA) as a tumor biomarker for recurrent disease.
OUTLINE:
Patients receive erlotinib hydrochloride orally (PO) daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) or stable disease (SD) undergo definitive local treatment (surgical resection, stereotactic radiosurgery, radiofrequency ablation, or conventional radiation therapy) to all remaining measurable sites of disease and then continue to receive erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue erlotinib hydrochloride without local therapy, and patients with progression of disease are removed from the study.
After completion of study treatment, patients are followed up every 8 weeks for 1 year and then every 12 weeks thereafter.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorHelena A. Yu