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

Official Title

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

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).

Trial Description

Primary Outcome:

• Objective Response Rate according to Response Evaluation Criteria in Solid Tumours version 1.1

• Progression Free Survival according to Response Evaluation Criteria in Solid Tumours version 1.1
• Duration of Response according to Response Evaluation Criteria in Solid Tumours version 1.1
• Disease Control Rate according to Response Evaluation Criteria in Solid Tumours version 1.1
• Tumour Shrinkage according to Response Evaluation Criteria in Solid Tumours version 1.1
• Overall Survival
• Time to Treatment Failure
• Effect of Osimertinib Rechallenge on Health Related Quality of Life Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-C30
• Effect of Osimertinib Rechallenge on Health Related Quality of Life Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-LC 13
• Effect of Osimertinib Rechallenge on Disease-Related Symptoms Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires EORTC QLQ-C30
• Effect of Osimertinib Rechallenge on Disease-Related Symptoms Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC QLQ-LC 13
• Objective Response Rate in the Atypical Epidermal Growth Factor Receptor Mutation Population
• Progression Free Survival according to Response Evaluation Criteria in Solid Tumours in the Atypical Epidermal Growth Factor Receptor Population
• Duration of Response according to Response Evaluation Criteria in Solid Tumours version 1.1 in the Atypical Epidermal Growth Factor Receptor Mutation Population
• Disease Control Rate according to Response Evaluation Criteria in Solid Tumours version 1.1 in the Atypical Epidermal Growth Factor Receptor Mutation Population
• Tumour Shrinkage according to Response Evaluation Criteria in Solid Tumours version 1.1 in the Atypical Epidermal Growth Factor Receptor Mutation Population
• Overall Survival in the Atypical Epidermal Growth Factor Receptor Mutation Population
• Time to Treatment Failure in the Atypical Epidermal Growth Factor Receptor Mutation Population

View this trial on ClinicalTrials.gov