Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

Exclusion Criteria

• •1. Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 \[L858R\] substitution mutations) are excluded. All subjects with non-squamous histology must have been tested locally for EGFR mutation status; use of an FDA-approved test is strongly encouraged (EGFR mutation testing may be performed during the Screening Period, Non-squamous subjects with unknown or indeterminate EGFR status may not be included).
• •2. Subjects with untreated CNS metastases are excluded.
• •3. Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
• •4. Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as Vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• •5. Treatment with other investigational drugs or other anti-cancer therapy, or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial
• •6. Radiographical evidence of cavitated or necrotic tumors
• •7. Centrally located tumors with radiographical evidence (CT or MRI) of local invasion of major blood vessels
• •8. History of clinically significant hemoptysis within the past 3 months
• •9. History of major thrombotic or clinically relevant major bleeding event in the past 6 months.
• •10. Known inherited predisposition to bleeding or thrombosis
• •11. Medical History and Concurrent Diseases
• •1. Any medical condition or serious uncontrolled or active infection with hepatitis or HIV that could be reactivated.
• •2. Other concurrent malignancies requiring intervention.
• •3. All toxicities attributed to a previous treatment for cancer other than alopecia or fatigue, must have resolved to Grade 1 (NCI CTCAE version 4) or baseline, prior to administration of study drug.
• •4. Prior treatment with tumor vaccines or other anti-tumor immune stimulating agents.
• •5. Prior treatment with Alectinib.
• •6. Prior treatment with Bevacizumab
• •7. Subjects with a history of interstitial lung disease.
• •8. Subjects must be recovered from the effects of major surgery, traumatic injury or substantially at least 7 days before the first dose of study treatment.
• •12. Physical Findings and Laboratory Tests
• •1. Positive for the surface antigen of hepatitis B virus (HBV HBsAg) or hepatitis C ribonucleic acid (HCV RNA) Evidence indicating acute or chronic infection
• •2. Known history of positive test for Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS).
• •13. Allergies and Adverse Drug Reactions to
• •1. History of severe hypersensitivity to other monoclonal antibodies.
• •2. Previous history of severe hypersensitivity reaction to paclitaxel.
• •3. History of allergy or intolerance (unacceptable adverse event) to components of the study drug, or herbal teas that contain Polysorbate 80.
• •14. Sexual and Reproductive Status
• •1. WOCBP pregnant or who are nursing
• •2. Women with a positive pregnancy test in recruitment or prior to administration of the study drug.
• •1. Any other serious medical condition or uncontrolled active infection, findings on physical examination, laboratory findings, altered mental status, or psychiatric condition that, in the investigator's opinion, would limit the ability of an individual to meet the requirements of study, significantly increase the risk to the subject, or which affects the interpretability of the study results.
• •2. Prisoners or subjects who are involuntarily incarcerated.
• •3. Subjects who are compulsorily admitted for treatment of a mental or physical illness (eg, infectious disease). Eligibility criteria for this study were carefully considered to ensure the safety of study subjects, and to ensure that the results of the study can be used