A Phase II Study of Combination Therapies for Advanced Non-Small Cell Lung Cancer with an EGFR Mutation that Has Grown Despite Osimertinib

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Full 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 (ORCHARD)

Purpose

Patients with non-small cell lung cancer (NSCLC) that contains a mutation in the EGFR gene typically receive EGFR inhibitors (such as osimertinib), but the cancer often becomes resistant to those drugs.

In this study, researchers are evaluating the safety and effectiveness of various drug combinations in people with advanced NSCLC with an EGFR mutation that has continued to grow despite osimertinib therapy. Patients in this study will have tumor tissue biopsied and tested to determine the appropriate treatment combination for each patient.

Patients will receive one of these treatment combinations:

  • Osimertinib plus savolitinib for patients with NSCLC that contains a high amount of a gene called MET. Savolitinib blocks the activity of the MET protein.
  • Osimertinib plus gefitinib for patients whose tumors contain a variation in the EGFR gene called C797X. Gefitinib blocks the activity of the EGFR C797X protein.
  • Osimertinib plus necitumumab, an antibody that blocks EGFR in a different way than osimertinib.
  • Durvalumab immunotherapy plus chemotherapy with pemetrexed and carboplatin. Durvalumab boosts the ability of the immune system to find and kill cancer cells.
  • Observation group: patients who cannot participate in one of the other treatment groups will receive a different therapy and be observed to see how they do.

Osimertinib, savolitinib, and gefitinib are taken orally (by mouth). 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 advanced NSCLC with an EGFR mutation that has continued to grow despite one prior regimen of osimertinib.
  • Patients must recover from the serious side effects of previous therapies before 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

19-312

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators