A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

Phase 3 Terminated 530 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.

Timeline

Start: 2016-02-11
Primary completion: 2017-12-21
Completion: 2017-12-21

Outcome

Missed primary endpoint

Stopped (Enrollment): “Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies”

registry analysis (superiority test); ASP8273 vs Erlotinib or Gefitinib; p = 0.992; Hazard Ratio (HR) 1.611 (95% CI 1.086 to 2.391); Log Rank NCT02588261 ↗

paper CONCLUSIONS: First-line ASP8273 did not show improved PFS or equivalent toxicities versus erlotinib/gefitinib. PMID 31070709 ↗

Publications

Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Erlotinib	Small molecule	150 mg	Oral
Comparator	Gefitinib	Small molecule	250 mg	Oral
Subject	naquotinib	Small molecule	300 mg	Oral