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Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Stage IV Lung Non-Small Cell Cancer AJCC v7 Clinical Trial

Official title:
A Phase 1B Study of AZD9291 in Combination With Navitoclax in EGFR-Mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor

Clinical Trial Summary

This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body (metastatic) or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of osimertinib (AZD9291) in combination with navitoclax in patients with EGFR-mutant non-small cell lung cancer (NSCLC) following resistance to prior EGFR-tyrosine kinase inhibitor (EGFR TKI). II. To evaluate the feasibility of treatment with AZD9291 plus navitoclax for patients with T790M-mediated acquired resistance to EGFR TKI. SECONDARY OBJECTIVES: I. To study the pharmacokinetic profile of the combination of AZD9291 plus navitoclax. II. To observe and record anti-tumor activity. CORRELATIVE OBJECTIVES: I. To study plasma genotype levels as a response biomarker in patients with EGFR-mutant lung cancer. II. To explore tissue biomarkers of apoptosis and their association with treatment response. OUTLINE: This is a phase Ib, dose-escalation study followed by a dose-expansion study. Patients receive navitoclax orally (PO) once daily (QD) on days 1-28 and osimertinib PO QD on days 4-28 (days 1-28 during dose-expansion). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Lung Non-Squamous Non-Small Cell Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage III Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7
Clinical Trial Details
NCT number NCT02520778
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1
Start date August 30, 2016
Completion date July 30, 2024
View Details
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