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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04427072
Registration number
NCT04427072
Ethics application status
Date submitted
9/06/2020
Date registered
11/06/2020
Date last updated
25/07/2023
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
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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).
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Secondary ID [1]
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2020-001578-31
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Secondary ID [2]
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CINC280A2301
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Universal Trial Number (UTN)
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Trial acronym
GeoMETry-III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Capmatinib
Treatment: Drugs - Docetaxel
Experimental: Capmatinib - 400mg of capmatinib tablets, administered orally twice daily
Active Comparator: Docetaxel - Docetaxel 75 mg/m2 solution administered by intravenous infusion on Day 1 of every 21-day cycle
Treatment: Drugs: Capmatinib
400mg of capmatinib tablets administered orally twice daily
Treatment: Drugs: Docetaxel
Docetaxel 75 mg/m2 by intravenous infusion every 21 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival (PFS) per blinded independent review committee (BIRC) using RECIST v1.1
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Assessment method [1]
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Progression free survival is defined as the time from the date of randomization to the date of the first documented progression assessed by BIRC according to RECIST 1.1, or death due to any cause
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Timepoint [1]
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From randomization to the date of first documented progression or death from any cause, whichever comes first, assessed up to approximately 21 months
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Secondary outcome [1]
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Overall response (ORR) per RECIST 1.1 by BIRC
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Assessment method [1]
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Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1.
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Timepoint [1]
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Up to approximately 21 months
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Secondary outcome [2]
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Overall response (ORR) per RECIST 1.1 by investigator
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Assessment method [2]
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Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1.
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Timepoint [2]
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Up to approximately 21 months
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Secondary outcome [3]
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Time to response (TTR) per RECIST 1.1 by BIRC
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Assessment method [3]
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Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1.
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Timepoint [3]
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From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
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Secondary outcome [4]
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Time to response (TTR) per RECIST 1.1 by investigator
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Assessment method [4]
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Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1.
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Timepoint [4]
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From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months
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Secondary outcome [5]
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Duration of response (DOR) per RECIST 1.1 by BIRC
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Assessment method [5]
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Time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause.
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Timepoint [5]
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From first documented response to first documented progression or death due to any cause, whichever comes first, assessed up to approximately 21 months
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Secondary outcome [6]
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Duration of response (DOR) per RECIST 1.1 by investigator
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Assessment method [6]
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Time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause.
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Timepoint [6]
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From first documented response to first documented progression or death due to any cause, whichever comes first, assessed up to approximately 21 months
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Secondary outcome [7]
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Disease Control Rate (DCR) per RECIST 1.1 by BIRC
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Assessment method [7]
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Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1
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Timepoint [7]
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Up to approximately 21 months
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Secondary outcome [8]
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Disease Control Rate (DCR) per RECIST 1.1 by investigator
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Assessment method [8]
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Percentage of participants with a BOR of confirmed CR, PR and SD assessed by local review according to RECIST 1.1
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Timepoint [8]
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Up to approximately 21 months
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Secondary outcome [9]
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Progression free survival (PFS) per investigator using RECIST v1.1
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Assessment method [9]
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Time from the date of randomization to the date of the first documented progression assessed by local review according to RECIST 1.1, or death due to any cause
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Timepoint [9]
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From randomization to the date of first documented progression or death from any cause, whichever comes first, assessed up to approximately 21 months
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Secondary outcome [10]
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Overall survival (OS)
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Assessment method [10]
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [10]
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From randomization to death due to any cause, assessed up to approximately 42 months
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Secondary outcome [11]
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Overall intracranial response rate (OIRR)
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Assessment method [11]
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Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per RANO-BM criteria.
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Timepoint [11]
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Up to approximately 21 months
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Secondary outcome [12]
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Duration of intracranial response (DOIR)
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Assessment method [12]
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Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer.
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Timepoint [12]
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From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months
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Secondary outcome [13]
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Time to intracranial response (TTIR)
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Assessment method [13]
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Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed.
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Timepoint [13]
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From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months
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Secondary outcome [14]
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Intracranial disease control rate (IDCR)
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Assessment method [14]
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Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC.
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Timepoint [14]
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Up to approximately 21 months
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Secondary outcome [15]
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Plasma capmatinib concentration
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Assessment method [15]
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Plasma concentrations of capmatinib. Blood samples will be collected at indicated time points for pharmacokinetic analysis.
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Timepoint [15]
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Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration is 21 days.
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Secondary outcome [16]
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Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
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Assessment method [16]
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EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Change from baseline in EORTC QLQ-C30 scores will be assessed
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Timepoint [16]
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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 is 21 days.
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Secondary outcome [17]
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Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
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Assessment method [17]
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EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The five domains of the questionnaire include pain, dyspnea, coughing and hemoptysis, and are based on their presence over the past week. All but the pain domain are scored on a 4 point Likert scale ranging from "not at all" to "very much". Pain is score based on its presence, hence yes or no. A higher score indicates a higher presence of symptoms.
Change from baseline in EORTC QLQ-LC13 scores will be assessed
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Timepoint [17]
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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 is 21 days.
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Secondary outcome [18]
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Change from baseline in score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire
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Assessment method [18]
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EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility.
Change from baseline in EQ-5D-5L scores will be assessed
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Timepoint [18]
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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 is 21 days.
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Secondary outcome [19]
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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)
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Assessment method [19]
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EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The five domains of the questionnaire include pain, dyspnea, coughing and hemoptysis, and are based on their presence over the past week. All but the pain domain are scored on a 4 point Likert scale ranging from "not at all" to "very much". Pain is score based on its presence, hence yes or no. A higher score indicates a higher presence of symptoms.
Time to symptom deterioration for chest pain, cough and dyspnea will be assessed
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Timepoint [19]
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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 is 21 days.
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Secondary outcome [20]
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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
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Assessment method [20]
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EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time to deterioration in QoL from EORTC-QLQ-C30 will be assessed.
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Timepoint [20]
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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 is 21 days.
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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 is:
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 has 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 be 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 pertains to all participants, including those who
have a MET?ex14 mutation result from a local test. Tumor samples must contain at least
10% tumor content.
6. Participants must have progressed on one or two prior lines of
- 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 be docetaxel naïve and candidates for single agent
chemotherapy (docetaxel). Treatment failure is 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.
- Participants must have a life expectancy of at least 3 months.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment with any MET inhibitor or HGF-targeting therapy.
- Participants with symptomatic central nervous system (CNS) metastases who are
neurologically unstable or have 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 ROS1and RET
rearrangement, BRAF mutation, KRAS mutation, NTRK fusion, etc.) which might be 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 increase the risk associated with study participation
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Leuven
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Country [2]
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Brazil
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State/province [2]
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SP
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Country [3]
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France
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State/province [3]
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Paris
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Country [4]
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France
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State/province [4]
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Pierre Benite
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Country [5]
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Germany
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State/province [5]
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Bayern
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Country [6]
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Germany
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State/province [6]
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Koeln
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Country [7]
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India
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State/province [7]
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Delhi
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Country [8]
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Italy
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State/province [8]
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MI
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Country [9]
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Italy
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State/province [9]
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RM
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Country [10]
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Korea, Republic of
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State/province [10]
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Seoul
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Country [11]
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Netherlands
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State/province [11]
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Nijmegen
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Country [12]
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Portugal
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State/province [12]
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Matosinhos
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Country [13]
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Spain
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State/province [13]
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Comunidad Valenciana
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Country [14]
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Spain
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State/province [14]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to learn whether the study drug (capmatinib) helps to control
lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe
when given to patients suffering from a particular type of lung cancer. This type of cancer
is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations
(called mutations) of a gene called MET, within a specific part of the gene called exon 14.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04427072
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04427072
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