TerminatedPhase 1 / Phase 2NCT02584634

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)

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

Checked against the public recordLast updated Jul 7, 2023 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations20
SponsorPfizer
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: Avelumab; Drug: PF-06463922; Drug: Crizotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

* 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory University Hospital MidtownAtlanta, Georgia
  • Emory University HospitalAtlanta, Georgia
  • The Emory ClinicAtlanta, Georgia
  • Winship Cancer Institute of Emory UniversityAtlanta, Georgia
  • Massachusetts General HospitalBoston, Massachusetts
  • Ophthalmic Consultants of Boston Inc (OCB)Boston, Massachusetts
  • Tennessee Oncology, PLLCNashville, Tennessee
  • Chris O'Brien LifehouseCamperdown, New South Wales
  • The Prince Charles HospitalChermside, Queensland
  • Peter MacCallum Cancer CentreMelbourne, Victoria
  • Royal Melbourne HospitalParkville, Victoria
  • Aichi cancer center central hospitalNagoya, Aichi-ken

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2023. Always confirm current availability with the study team.

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