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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.