- Have a diagnosis of NSCLC with at least 1 measurable lesion assessable using standard
techniques by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
- Have T790M-positive status using a test validated and performed locally after disease
progression on EGFR tyrosine kinase inhibitor (TKI) treatment.
- Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the
time of enrollment.
- Have serum albumin that is â‰¥25 grams per liter at the time of enrollment.
- Have adequate organ function, with all screening labs performed within 7 days of
- Have a life expectancy of â‰¥3 months.
- Have resolution, except where otherwise stated in the inclusion criteria, of all
clinically significant toxic effects of prior systemic cancer therapy, surgery, or
radiotherapy to Grade â‰¤1 by National Cancer Institute Common Terminology Criteria for
Adverse Events (CTCAE) Version 4.0.
- Previous treatment with an EGFR monoclonal antibody (except for past treatment for
squamous cell carcinoma of head and neck or metastatic colorectal cancer).
- Previous treatment with osimertinib or third generation EGFR TKIs.
- Participants with symptomatic or growing brain metastases less than 4 weeks prior to
- History of drug-induced interstitial lung disease (ILD), ILD, or radiation pneumonitis
requiring treatment with steroid prior to study enrollment, or any evidence of
clinically active ILD.
- Have a significant bleeding disorder or vasculitis or had a Grade â‰¥3 bleeding episode
within 12 weeks prior to enrollment. Participants with a history of gross hemoptysis
(defined as bright red blood of â‰¥1/2 teaspoon) within 2 months prior to enrollment are
- Have experienced any arterial thrombotic event or arterial thromboembolic event,
including myocardial infarction, unstable angina (history or evidence of current
clinically relevant coronary artery disease of current â‰¥Class III as defined by
Canadian Cardiovascular Society Angina Grading Scale or congestive heart failure of
current â‰¥Class III as defined by the New York Heart Association), cerebrovascular
accident, or transient ischemic attack, within 6 months prior to enrollment.
- Have a history of deep vein thrombosis, pulmonary embolism, or any other significant
venous thromboembolism (venous catheter thrombosis or superficial venous thrombosis
not considered "significant") during the 3 months prior to study enrollment.
Participants with venous thromboembolism occurring 3 to 6 months prior to study
enrollment are allowed, if being treated with low molecular weight heparin.
- Have a history of gastrointestinal perforation and/or fistula within 6 months prior to
- Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection (hemicolectomy or extensive small intestine resection with
chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Have uncontrolled hypertension, as defined in CTCAE Version 4.0, prior to initiating
study treatment, despite antihypertensive intervention. CTCAE Version 4.0 defines
uncontrolled hypertension as Grade >2 hypertension; clinically, the participant
continues to experience elevated blood pressure (systolic >160 millimeters of mercury
[mmHg] and/or diastolic >100 mmHg) despite medications.
- Are receiving chronic therapy with any of the following medications within 7 days
prior to enrollment:
- nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen,
naproxen, or similar agents).
- other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or
- Have radiologically documented evidence of major blood vessel invasion or encasement
- Have radiographic evidence of pulmonary intratumor cavitation, regardless of tumor
- Are receiving concurrent treatment with other anticancer therapy, including other
chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy
or radiotherapy treatment to more than 30% of the bone marrow or with a wide field of
radiation within 4 weeks prior to enrollment.
- Have abnormal cardiac findings.
- Have undergone chest irradiation within 2 weeks prior to study drug administration,
have not recovered from all radiation-related toxicities, or requires corticosteroids.
A 2-week washout is permitted for focal palliative radiation to non-central nervous