Brief Title
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)
Official Title
A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined
with either crizotinib or PF-06463922.
Detailed 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
First two cycles dose limiting toxicities (DLTs) for Group A and Group B
Secondary Outcome
Disease Control (DC)
Condition
Non-Small Cell Lung Cancer
Intervention
Avelumab
Study Arms / Comparison Groups
Group A
Description: ALK negative Non-Small Cell Lung Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
43
Start Date
December 18, 2015
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02584634
Organization ID
B9991005
Secondary IDs
2015-001879-43
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
July 2020