A Phase II Study of Osimertinib Alone or with Chemotherapy for Patients with Metastatic EGFR-Mutant Lung Cancers Who Have Detectable Tumor DNA in the Blood After Starting Osimertinib


Full Title

A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients with Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib


Osimertinib is a standard treatment for metastatic non-small cell lung cancer (NSCLC) that has a change (mutation) in the EGFR gene. Researchers think that adding chemotherapy to osimertinib could make treatment more effective.

The purpose of this study is to compare osimertinib treatment alone with osimertinib plus chemotherapy in patients with EGFR-mutant metastatic NSCLC who have detectable levels of EGFR-mutant tumor DNA in their blood after starting osimertinib alone. Having detectable EGFR mutations in the blood after receiving osimertinib alone indicates a patient may have a shorter time before the cancer starts growing again.

Patients in this study will be randomly assigned to receive osimertinib alone or with the chemotherapy drugs carboplatin and pemetrexed. These chemotherapy drugs may slow the production of new cancer cells that researchers believe are resistant to osimertinib. Osimertinib is taken orally (by mouth) and carboplatin and pemetrexed are given intravenously (by vein).

Who Can Join

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

  • Patients must have EGFR-mutant NSCLC and EGFR-mutant tumor DNA detected in their blood after starting treatment with osimertinib.
  • Patients may not have previously received chemotherapy for their metastatic cancer.
  • 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. Helena Yu at 646-608-3912.




Phase II (phase 2)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID