An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-na ve EGFR-mutant Locally Advanced or Metastatic NSCLC

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Nsclc
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy. 2) Patients must have one of the following: •NSCLC which harbors Epidermal Growth Factor (EGFR) Exon 19 deletion. •NSCLC which harbors EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion/mutation testing has not been done, it should be ordered per standard of care. 3) Patients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of < = 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent.

You may not be eligible for this study if the following are true:

  • 1) Previous treatment with any EGFR TKIs, including erlotinib, gefitinib, afatinib, avitinib, dacomitinib, rociletinib, or osimertinib. 2) Previous treatment with any anti-Vascular Endothelial Growth Factor (VEGF) medications, including vandetinib, nintedanib, bevacizumab, or ramucirumab. 3) Patients currently receiving (or unable to stop use prior to receiving the first dose of study (treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.


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