A Phase I Study Evaluating Combination Osimertinib, Platinum, and Etoposide for Patients with Metastatic EGFR-Mutant Lung Cancers

Full Title

Phase 1 Study of Combination Osimertinib, Platinum, Etoposide for Patients with Metastatic EGFR Mutant Lung Cancers with Concurrent RB1 and TP53 Alterations

Purpose

Most non-small cell lung cancers (NSCLC) with mutations in EGFR, the epidermal growth factor receptor, are treated with EGFR-targeting drugs (such as erlotinib, afatinib, or gefitinib), but the cancers eventually progress. Osimertinib is a newer EGFR inhibitor for NSCLC that is now used as the first line of treatment as well. Patients may initially respond to treatment with osimertinib, but any cancer cells that remain can develop resistance to this treatment, too, and the disease may continue to grow over time.

Etoposide, cisplatin, and carboplatin are standard drugs used to treat small cell lung cancer. Rarely, some non-small cell lung cancers can change and become small cell lung cancers. In this study, researchers are evaluating the safety of the combination of osimertinib, cisplatin or carboplatin, and etoposide in patients with metastatic EGFR-mutant NSCLC. The reason these drugs are being combined is to see whether they can prevent small cell transformation and enable patients to respond to osimertinib for a longer period of time. Osimertinib is taken orally (by mouth), while the other medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic EGFR-mutant NSCLC.
  • Patients must also have RB1 and P53 mutations.
  • Patients should either have not started an EGFR inhibitor or may have started osimertinib within the 6 weeks prior to entering the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.

Protocol

18-211

Phase

I

Investigator

Co-Investigators