Study of Advanced Non-Small Cell Lung Cancer that has Progressed on First-Line Osimertinib Therapy

Clinical Trial Title

A biomarker-directed phase 2 platform study in patients with advanced non-small cell lung cancer whose disease has progressed on first-line osimertinib therapy.

National Clinical Trial Number:

NCT03944772

Clinical Trial Protocol Description:

This is a Phase 2 study for patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on 1st-line treatment with the drug osimertinib. Biomarker testing will be done on qualifying patients, and they will be assigned a treatment group (A, B, or C) based on the test results. Eligible patients will be assigned to receive: osimertinib + savolitinib (Group A) or osimertinib + gefitinib (Group A) or osimertinib + necitumumab (Groups A and B) or carboplatin + pemetrexed+ durvalumb (Group B). Those who do not qualify for Groups A or B based on their biomarker profile will be assigned to Group C (observation only, with physician's choice of treatment).

Patients will be treated until disease progression, death, withdrawal of consent, or request by the study sponsor or treating physician. Following completion of (or discontinuation from) treatment, patients will be followed for survival every 3 months for about 2 years.

This study is hoping to gain more information on the optimal treatment for patients with NSCLC who have progressed on first-line osimertinib, and how the molecular mechanisms underlying that resistance can be overcome. Currently, there are very limited data and limited understanding of the underlying mechanisms that contribute to resistance to osimertinib in a first-line setting.

ClinicalTrials.gov Identifier: NCT03944772

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are at least 18 years of age at the time of study consent.
  • Have locally advanced or metastatic disease (ie, advanced NSCLC) not amenable to curative surgery or radiotherapy.
  • Have received only 1 line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by the study doctor.
  • Have evidence of disease progression on treatment with osimertinib 80 mg once daily.

You will be excluded from the study if any of the following criteria apply to you:

  • Have disease that has progressed within the first 3 months of osimertinib treatment.
  • Have had prior or concurrent treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

Mary Jo Fidler, MD

Contact Information

Rush Cancer Center Clinical Trials Office