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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02584634




Registration number
NCT02584634
Ethics application status
Date submitted
21/10/2015
Date registered
22/10/2015
Date last updated
23/05/2019

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2015-001879-43
Secondary ID [2] 0 0
B9991005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - PF-06463922
Treatment: Drugs - Crizotinib

Experimental: Group A - ALK negative Non-Small Cell Lung Cancer

Experimental: Group B - ALK positive Non-Small Cell Lung Cancer


Treatment: Drugs: Avelumab
Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg

Treatment: Drugs: PF-06463922
Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.

Treatment: Drugs: Crizotinib
Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First two cycles dose limiting toxicities (DLTs) for Group A and Group B
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Confirmed Overall Response (OR) per RECIST v.1.1 for Group A - 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.
Timepoint [2] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Disease Control (DC) - 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.
Timepoint [1] 0 0
Up to 60 months.
Secondary outcome [2] 0 0
Confirmed Overall Response (Group B) - 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.
Timepoint [2] 0 0
Up to 60 months
Secondary outcome [3] 0 0
Overall Survival - Time from start date to the date of death due to any cause.
Timepoint [3] 0 0
Up to 60 months
Secondary outcome [4] 0 0
AUClast - Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (Clast)
Timepoint [4] 0 0
Avelumab: Day 8, Crizotinib & PF-06463922: 24 hours
Secondary outcome [5] 0 0
AUCtau - Area under the plasma concentration time profile after single dose from time zero to the next dose
Timepoint [5] 0 0
Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Secondary outcome [6] 0 0
Cmax - Maximum observed plasma concentration
Timepoint [6] 0 0
Avelumab: Day 1, Crizotinib & PF-06463922: Day 1
Secondary outcome [7] 0 0
Tmax - Time for Cmax
Timepoint [7] 0 0
Avelumab: Day 1, Crizotinib & PF-06463922: Day 1
Secondary outcome [8] 0 0
t½a - Terminal half life
Timepoint [8] 0 0
Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Secondary outcome [9] 0 0
Ctrough - Predose concentration during multiple dosing
Timepoint [9] 0 0
Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1
Secondary outcome [10] 0 0
CL/Fa - Apparent clearance
Timepoint [10] 0 0
Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Secondary outcome [11] 0 0
Vz/Fa - Apparent volume of distribution
Timepoint [11] 0 0
Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Secondary outcome [12] 0 0
MRAUCtau - Metabolite to parent ratio for AUCtau
Timepoint [12] 0 0
Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1
Secondary outcome [13] 0 0
MRCmax - Metabolite to parent ratio for Cmax
Timepoint [13] 0 0
Avelumab: Day 1, Crizotinib & PF=06463922: Day 1
Secondary outcome [14] 0 0
tumor tissue biomarkers - Tumor tissue biomarkers, including but not limited to, PD-L1 expression and tumor infiltrating CD8+ T cells by immunohistochemistry (IHC)
Timepoint [14] 0 0
baseline
Secondary outcome [15] 0 0
Duration of Response (DR) - 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.
Timepoint [15] 0 0
Up to 60 months
Secondary outcome [16] 0 0
Time to Treatment Response (TTR) - 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.
Timepoint [16] 0 0
Up to 60 months
Secondary outcome [17] 0 0
Progression Free Survival (PFS) - 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.
Timepoint [17] 0 0
Up to 60 months

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Japan
State/province [4] 0 0
Aichi
Country [5] 0 0
Japan
State/province [5] 0 0
Fukuoka
Country [6] 0 0
Japan
State/province [6] 0 0
Koto-ku, Tokyo
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Gyeonggi-do
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined
with either crizotinib or PF-06463922.
Trial website
https://clinicaltrials.gov/show/NCT02584634
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications