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)

Pfizer

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: PF-06463922; Drug: Avelumab; Drug: Crizotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02584634

JAVELIN LUNG 101 (Other Identifier)

B9991005

2015-001879-43 (EudraCT Number)

Details and patient eligibility

About

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

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Group A

Experimental group

Description:

ALK negative Non-Small Cell Lung Cancer

Treatment:

Drug: Crizotinib

Drug: Avelumab

Group B

Experimental group

Description:

ALK positive Non-Small Cell Lung Cancer

Treatment:

Drug: PF-06463922

Drug: Avelumab