A Phase II Study of Local Consolidation Therapy after Osimertinib Compared with Osimertinib Alone in People with Metastatic Non-Small Cell Lung Cancer

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Full Title

Randomized Phase II Trial of Local Consolidation Therapy (LCT) after Osimertinib for Patients with EGFR Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)

Purpose

Most non-small cell lung cancers (NSCLC) with mutations in a protein called EGFR 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. 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.

In this study, researchers want to see if adding “local consolidation therapy” (radiation therapy, surgery, or both) after initial osimertinib treatment is more effective than continued treatment with osimertinib alone for patients with metastatic EGFR-mutated NSCLC. After initial therapy with osimertinib, patients will be randomly assigned to one of these groups:

  • Treatment with radiation therapy, surgery, or both. Some patients may continue to take osimertinib as well.
  • Continued treatment with osimertinib only.

Osimertinib is taken orally (by mouth).

Eligibility

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

  • Patients must have stage IIIB or IV NSCLC that contains mutated EGFR.
  • For patients who had initial osimertinib treatment, their cancers may not have continued to grow during therapy.
  • Patients should recover from the serious side effects of prior treatments.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Daniel Gomez at 212-639-2087.

Protocol

19-425

Phase

II

Investigator

Co-Investigators