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)



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 18, 2015
End Date:March 5, 2020

Use our guide to learn which trials are right for you!

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

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

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.

- 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.
We found this trial at
10
sites
Camperdown, New South Wales 2050
8650
mi
from
Camperdown,
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
Boston, MA
Click here to add this to my saved trials
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
Click here to add this to my saved trials
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
803
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
Click here to add this to my saved trials
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
803
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boston, Massachusetts 02114
1444
mi
from
Boston, MA
Click here to add this to my saved trials
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
558
mi
from
Nashville, TN
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
618
mi
from
Nashville, TN
Click here to add this to my saved trials