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 summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAvelumab and PF-06463922

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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.

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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