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)

Related Clinical Trial
Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India An Observational Research Of Crizotinib’s Hepatic Toxicity In Non-small Cell Lung Cancer Patients 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) LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib. A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

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