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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04427072




Registration number
NCT04427072
Ethics application status
Date submitted
9/06/2020
Date registered
11/06/2020

Titles & IDs
Public title
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
Scientific title
A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (MET?ex14).
Secondary ID [1] 0 0
2020-001578-31
Secondary ID [2] 0 0
CINC280A2301
Universal Trial Number (UTN)
Trial acronym
GeoMETry-III
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Capmatinib
Treatment: Drugs - Docetaxel

Experimental: Capmatinib - 400 mg, capmatinib tablets, administered orally twice daily

Active comparator: Docetaxel - Docetaxel 75 mg/m\^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle


Treatment: Drugs: Capmatinib
400 mg, capmatinib tablets, administered orally twice daily

Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m\^2 by intravenous infusion every 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Per Blinded Independent Review Committee (BIRC) Using RECIST v1.1
Timepoint [1] 0 0
From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months
Secondary outcome [1] 0 0
Overall Response (ORR) Per RECIST 1.1 by BIRC
Timepoint [1] 0 0
Up to approximately 21 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) Per RECIST 1.1 by Investigator
Timepoint [2] 0 0
Up to approximately 21 months
Secondary outcome [3] 0 0
Time to Response (TTR) Per RECIST 1.1 by BIRC
Timepoint [3] 0 0
From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
Secondary outcome [4] 0 0
Time to Response (TTR) Per RECIST 1.1 by Investigator
Timepoint [4] 0 0
From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
Secondary outcome [5] 0 0
Duration of Response (DOR) Per RECIST 1.1 by BIRC
Timepoint [5] 0 0
From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months
Secondary outcome [6] 0 0
Duration of Response (DOR) Per RECIST 1.1 by Investigator
Timepoint [6] 0 0
From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR) Per RECIST 1.1 by BIRC
Timepoint [7] 0 0
Up to approximately 21 months
Secondary outcome [8] 0 0
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator
Timepoint [8] 0 0
Up to approximately 21 months
Secondary outcome [9] 0 0
Progression-free Survival (PFS) Per Investigator Using RECIST v1.1
Timepoint [9] 0 0
From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
From randomization to death due to any cause, assessed up to approximately 36 months
Secondary outcome [11] 0 0
Overall Intracranial Response Rate (OIRR)
Timepoint [11] 0 0
Up to approximately 21 months
Secondary outcome [12] 0 0
Duration of Intracranial Response (DOIR)
Timepoint [12] 0 0
From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months
Secondary outcome [13] 0 0
Time to Intracranial Response (TTIR)
Timepoint [13] 0 0
From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months
Secondary outcome [14] 0 0
Intracranial Disease Control Rate (IDCR)
Timepoint [14] 0 0
Up to approximately 21 months
Secondary outcome [15] 0 0
Plasma Capmatinib Concentration
Timepoint [15] 0 0
Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days.
Secondary outcome [16] 0 0
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Timepoint [16] 0 0
Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Secondary outcome [17] 0 0
Change From Baseline in Score as Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
Timepoint [17] 0 0
Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Secondary outcome [18] 0 0
Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Timepoint [18] 0 0
Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.
Secondary outcome [19] 0 0
Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
Timepoint [19] 0 0
Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.
Secondary outcome [20] 0 0
Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Timepoint [20] 0 0
Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.

Eligibility
Key inclusion criteria
Key

* Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC (according to Version 8 of the American Joint Committee on Cancer (AJCC) Staging Manual) at the time of study entry.
* Histologically or cytologically confirmed diagnosis of NSCLC that was:

1. EGFR wt. Assessed as part of participant's standard of care by a validated test for EGFR mutations as per local guidelines. The EGFR wt status (for EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations.
2. AND ALK rearrangement negative. Assessed as part of participant's standard of care by a validated test.
3. AND had MET?ex14 mutation as determined by Novartis-designated central laboratory or by locally performed, tissue-based test, validated according to local regulation, from a Clinical Laboratory Improvement Amendments (CLIA)-certified US laboratory or an accredited local laboratory outside of the US. The positive MET?ex14 mutation result as determined per local test must have been documented in the participant's source documents and in the CRF prior to entering main screening.
* Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) with quality and quantity sufficient to allow assessment of MET?ex14 mutation status (as defined in the study [laboratory manual]). This pertained to all participants, including those who had a MET?ex14 mutation result from a local test. Tumor samples must have contained at least 10% tumor content.

6. Participants must have progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must have been docetaxel naïve and candidates for single agent chemotherapy (docetaxel). Treatment failure was defined as documented disease progression or intolerance to treatment, however, participants must have progressed on or after the last therapy before study entry.
* At least one measurable lesion as defined by RECIST 1.1
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Life expectancy of at least 3 months.

Key
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any MET inhibitor or HGF-targeting therapy.
* Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* Participants with known druggable molecular alterations (such as ROS1 and RET rearrangement, BRAF mutation, KRAS mutation, NTRK fusion, etc.) which might have been a candidate for alternative targeted therapies.
* Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
* Substance abuse, active infection or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may have increased the risk associated with study participation.

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
Crossover
Other design features
Phase
Phase 3
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
25/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2023
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Pleven
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
France
State/province [5] 0 0
Caen
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Pierre Benite
Country [8] 0 0
Germany
State/province [8] 0 0
Bavaria
Country [9] 0 0
Germany
State/province [9] 0 0
Bayern
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Koeln
Country [12] 0 0
Germany
State/province [12] 0 0
Oldenburg
Country [13] 0 0
Hungary
State/province [13] 0 0
Pest
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
India
State/province [15] 0 0
Delhi
Country [16] 0 0
India
State/province [16] 0 0
Maharashtra
Country [17] 0 0
India
State/province [17] 0 0
Tamil Nadu
Country [18] 0 0
Italy
State/province [18] 0 0
MI
Country [19] 0 0
Italy
State/province [19] 0 0
RM
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Lithuania
State/province [21] 0 0
Vilnius
Country [22] 0 0
Malaysia
State/province [22] 0 0
Pahang
Country [23] 0 0
Malaysia
State/province [23] 0 0
Wilayah Persekutuan
Country [24] 0 0
Malaysia
State/province [24] 0 0
Pulau Pinang
Country [25] 0 0
Netherlands
State/province [25] 0 0
Nijmegen
Country [26] 0 0
Portugal
State/province [26] 0 0
Lisboa
Country [27] 0 0
Portugal
State/province [27] 0 0
Matosinhos
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Nizhniy Novgorod
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Omsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Pushkin Saint Petersburg
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St- Petersburg
Country [32] 0 0
South Africa
State/province [32] 0 0
Western Cape
Country [33] 0 0
Spain
State/province [33] 0 0
Andalucia
Country [34] 0 0
Spain
State/province [34] 0 0
Asturias
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
Thailand
State/province [37] 0 0
Hat Yai
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
Vietnam
State/province [39] 0 0
Hanoi

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
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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/NCT04427072