Description:
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined
with either crizotinib or PF-06463922.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
B9991005
- SECONDARY ID:
2015-001879-43
- SECONDARY ID:
JAVELIN LUNG 101
- NCT ID:
NCT02584634
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Avelumab | MSB0010718C | Group A |
PF-06463922 | | Group B |
Crizotinib | PF-02341066 | Group A |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Group A | Experimental | ALK negative Non-Small Cell Lung Cancer | |
Group B | Experimental | ALK positive Non-Small Cell Lung Cancer | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | First two cycles dose limiting toxicities (DLTs) for Group A and Group B |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Complete response (CR) or Partial Response (PR) from start date (first dose of study treatment) until disease progression or death.
Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. |
Secondary Outcome Measures
Measure: | Disease Control (DC) |
Time Frame: | Up to 60 months. |
Safety Issue: | |
Description: | DC is defined as Best Overall Response of CR, PR, or Stable Disease (SD). Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. |
Measure: | Confirmed Overall Response (Group B) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | CR or PR from start date until disease progression or death. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. |
Measure: | Overall Survival |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | Time from start date to the date of death due to any cause. |
Measure: | AUClast |
Time Frame: | Avelumab: Day 8, Crizotinib & PF-06463922: 24 hours |
Safety Issue: | |
Description: | Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (Clast) |
Measure: | AUCtau |
Time Frame: | Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Area under the plasma concentration time profile after single dose from time zero to the next dose |
Measure: | Cmax |
Time Frame: | Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Maximum observed plasma concentration |
Measure: | Tmax |
Time Frame: | Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Time for Cmax |
Measure: | t½a |
Time Frame: | Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Terminal half life |
Measure: | Ctrough |
Time Frame: | Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Predose concentration during multiple dosing |
Measure: | CL/Fa |
Time Frame: | Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Apparent clearance |
Measure: | Vz/Fa |
Time Frame: | Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 |
Safety Issue: | |
Description: | Apparent volume of distribution |
Measure: | MRAUCtau |
Time Frame: | Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1 |
Safety Issue: | |
Description: | Metabolite to parent ratio for AUCtau |
Measure: | MRCmax |
Time Frame: | Avelumab: Day 1, Crizotinib & PF=06463922: Day 1 |
Safety Issue: | |
Description: | Metabolite to parent ratio for Cmax |
Measure: | tumor tissue biomarkers |
Time Frame: | baseline |
Safety Issue: | |
Description: | Tumor tissue biomarkers, including but not limited to, PD-L1 expression and tumor infiltrating CD8+ T cells by immunohistochemistry (IHC) |
Measure: | Duration of Response (DR) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | DR is defined, for patients with an objective response, as the time from first documentation of objective response (CR or PR) to the date of first documentation of objective progression of disease or death due to any cause. |
Measure: | Time to Treatment Response (TTR) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | TTR is defined, for patients with an objective response, as the time from the start date to the first documentation of objective response (CR or PR) which is subsequently confirmed. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 60 months |
Safety Issue: | |
Description: | PFS is defined as the time from start date to the date of the first documentation of PD or death due to any cause, whichever occurs first. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Pfizer |
Trial Keywords
- Non-Small Cell Lung Cancer
- NSCLC
- ALK
- avelumab
- crizotinib
- PF-06463922
Last Updated
June 3, 2021