Lung Cancer Clinical Trial

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)

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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Full Description

This is a Phase 1b/2, open label, multi center, multiple dose, safety, pharmacokinetic and pharmacodynamic study of Group A and Group B in cohorts of adult patients with locally advanced or metastatic NSCLC.

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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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT02584634

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 17 Locations for this study

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Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
The Emory Clinic
Atlanta Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston Massachusetts, 02114, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
The Prince Charles Hospital
Chermside Queensland, 4032, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Aichi cancer center central hospital
Nagoya Aichi, 464-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo , 135-8, Japan
National Cancer Center
Goyang-Si Gyeonggi-do, 10408, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Institut Catala d'Oncologia de Badalona
Badalona Barcelona, 08916, Spain
Hospital Quiron Barcelona
Barcelona , 08023, Spain
Hospital Universitari de la Vall d'Hebron
Barcelona , 08035, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT02584634

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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