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

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information prior to registration.

Age ≥ 18 years at the time of consent.

Histologically or cytologically confirmed non-squamous, non-small cell lung cancer.

Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.

Ability to take pills by mouth.

Previous treatment with cytotoxic chemotherapy or immunotherapy is allowed.


Exclusion Criteria


Previous treatment with any EGFR TKIs, including erlotinib, gefitinib, afatinib, avitinib, dacomitinib, rociletinib, or osimertinib.
 
Previous treatment with any anti-VEGF medications, including vandetinib, nintedanib, bevacizumab, or ramucirumab.

Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.

Patients with uncharacterized eye disorders.

Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.

Have undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial