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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)
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)

NCT02584634

TerminatedPhase 1, Phase 2

Sponsor: Pfizer

Conditions: Non-Small Cell Lung Cancer

Interventions: Avelumab, PF-06463922, Crizotinib

Countries: United States, Australia, Japan, South Korea, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (20)
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Nashville, Tennessee, United States
  • Camperdown, New South Wales, Australia
  • Chermside, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Parkville, Victoria, Australia
  • Nagoya, Aichi-ken, Japan
  • Fukuoka, Japan
  • Koto-ku, Tokyo, Japan
  • Goyang-si, Gyeonggi-do, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Badalona, Barcelona, Spain
  • Barcelona, Spain
  • Barcelona, Spain