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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04139317




Registration number
NCT04139317
Ethics application status
Date submitted
14/10/2019
Date registered
25/10/2019

Titles & IDs
Public title
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1= 50%
Scientific title
A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1= 50%
Secondary ID [1] 0 0
2019-002660-27
Secondary ID [2] 0 0
CINC280I12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 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 - Capmatinib
Treatment: Other - Pembrolizumab

Experimental: Capmatinib 400mg BID + pembrolizumab 200mg Q3W - Capmatinib (INC280) 400 mg orally twice daily (BID) in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W)

Active comparator: Pembrolizumab 200mg Q3W - Pembrolizumab 200 mg intravenously every 3 weeks (Q3W)


Treatment: Drugs: Capmatinib
INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle.

Treatment: Other: Pembrolizumab
Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1
Timepoint [1] 0 0
Up to 1.3 years
Secondary outcome [1] 0 0
Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1
Timepoint [1] 0 0
Up to 1.3 years
Secondary outcome [2] 0 0
Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1
Timepoint [2] 0 0
Up to 1.3 years
Secondary outcome [3] 0 0
Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1
Timepoint [3] 0 0
Up to 1.3 years
Secondary outcome [4] 0 0
Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1
Timepoint [4] 0 0
Up to 1.3 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 2.1 years
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From first dose of study treatment to 30 days after last dose, up to 2.1 years
Secondary outcome [7] 0 0
Maximum Observed Plasma Concentration (Cmax) of Capmatinib
Timepoint [7] 0 0
pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
Secondary outcome [8] 0 0
Time to Reach Maximum Plasma Concentration (Tmax) of Capmatinib
Timepoint [8] 0 0
pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
Secondary outcome [9] 0 0
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Capmatinib
Timepoint [9] 0 0
pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
Secondary outcome [10] 0 0
Trough Serum Concentration (Ctrough) of Pembrolizumab
Timepoint [10] 0 0
pre-dose on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1 and Cycle 12 Day 1. The duration of one cycle was 21 days.
Secondary outcome [11] 0 0
Number of Participants With Anti-pembrolizumab Antibodies
Timepoint [11] 0 0
Baseline (pre-dose), up to 8 months

Eligibility
Key inclusion criteria
* Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
* Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
* Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS = 50%)
* ECOG performance status score = 1
* Have at least 1 measurable lesion by RECIST 1.1
* Have adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with a MET inhibitor or HGF-targeting therapy
* Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
* Have untreated symptomatic central nervous system (CNS) metastases
* Clinically significant, uncontrolled heart diseases
* Prior palliative radiotherapy for bone lesions = 2 weeks prior to starting study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2023
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Wollongong
Recruitment hospital [2] 0 0
Novartis Investigative Site - North Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Shepparton
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
3630 - Shepparton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Yvoir
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Czechia
State/province [3] 0 0
Ostrava Vitkovice
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Strasbourg Cedex
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Koeln
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
Country [10] 0 0
Greece
State/province [10] 0 0
Thessaloniki
Country [11] 0 0
Hong Kong
State/province [11] 0 0
Shatin New Territories
Country [12] 0 0
India
State/province [12] 0 0
Maharashtra
Country [13] 0 0
India
State/province [13] 0 0
West Bengal
Country [14] 0 0
India
State/province [14] 0 0
Delhi
Country [15] 0 0
Italy
State/province [15] 0 0
AN
Country [16] 0 0
Italy
State/province [16] 0 0
PN
Country [17] 0 0
Japan
State/province [17] 0 0
Aichi
Country [18] 0 0
Japan
State/province [18] 0 0
Kanagawa
Country [19] 0 0
Malaysia
State/province [19] 0 0
Sarawak
Country [20] 0 0
Malaysia
State/province [20] 0 0
Kuala Lumpur
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amersfoort
Country [22] 0 0
Netherlands
State/province [22] 0 0
Breda
Country [23] 0 0
Netherlands
State/province [23] 0 0
Zwolle
Country [24] 0 0
Spain
State/province [24] 0 0
Catalunya
Country [25] 0 0
Spain
State/province [25] 0 0
Comunidad Valenciana
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Taiwan
State/province [28] 0 0
Changhua
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taichung
Country [30] 0 0
Thailand
State/province [30] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04139317