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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)

Last updated on October 10, 2018

FOR MORE INFORMATION
Study Location
Emory University Hospital Midtown
Atlanta, Georgia, 30308 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02584634
Pfizer
Active, not recruiting
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)

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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)
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.
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Avelumab
    Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
    Other Name: MSB0010718C
  • Drug: PF-06463922
    Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
  • Drug: Crizotinib
    Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
    Other Name: PF-02341066
  • Experimental: Group A
    ALK negative Non-Small Cell Lung Cancer
    Interventions:
    • Drug: Avelumab
    • Drug: Crizotinib
  • Experimental: Group B
    ALK positive Non-Small Cell Lung Cancer
    Interventions:
    • Drug: Avelumab
    • Drug: PF-06463922
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
August 9, 2020
February 15, 2019   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Japan,   Korea, Republic of,   Spain,   United States
France
 
NCT02584634
B9991005
2015-001879-43 ( EudraCT Number )
JAVELIN LUNG 101 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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