drugset / Trial / NCT04335292

Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

NCT04335292

Phase 2 Recruiting 200 enrolled Mark Vincent AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy. The repeat of osimertinib following previous treatment failure is investigational, although supported by scientific rationale. The dosing and scheduling of osimertinib follows its use in approved settings. The investigators examine its tolerability and efficacy in this setting to ensure osimertinib is a safe third-line option for patients with Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer(aNSCLC).

Timeline

Start
2021-01-06
Primary completion
2026-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Osimertinib Small molecule 80 mg Oral
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified
Background Pemetrexed Small molecule