Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

• Status: Active, not recruiting
• Trial end date: 2021-10-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Avelumab; Crizotinib

Criteria

• Inclusion Criteria

• Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and Group B must be ALK positive NSCLC

• Group A at least one prior regimen of therapy

• Group B any number of prior regimens.

• Mandatory tumor tissue available

• At least one measurable lesion

• ECOG Performance status 0 or 1

• Adequate bone marrow, renal, liver and pancreatic function

• Negative pregnancy test for females of childbearing potential

• Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)

Exclusion Criteria:

• No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody.

• No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history

• No active infection requiring systemic therapy

• Prior organ transplantation including allogenic stem cell transplantation.