Viewing Study NCT04427072



Ignite Creation Date: 2024-05-06 @ 2:47 PM
Last Modification Date: 2024-10-26 @ 1:37 PM
Study NCT ID: NCT04427072
Status: COMPLETED
Last Update Posted: 2023-11-30
First Post: 2020-06-09

Brief 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
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official 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 IIIBIIIC or IV NSCLC Harboring MET Exon 14 Skipping Mutation METΔex14
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GeoMETry-III
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
Detailed Description: Approximately 90 patients with advanced or metastatic lung cancer with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor EGFR or anaplastic lymphoma kinase ALK genes will be enrolled in this study Participants will be randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio The randomization will be stratified by prior lines of systemic therapy received for advancedmetastatic disease one line vs two lines

During treatment visits will be scheduled every 21 days

For all participants the respective treatment either with capmatinib or docetaxel may be continued beyond initial disease progression as per RECIST 11 as assessed by the investigator and confirmed by BIRC if in the judgment of the investigator there is evidence of clinical benefit and the participant wishes to continue on the study treatment After treatment discontinuation all participants will be followed for safety evaluations during the safety follow-up period and the participants status will be collected every 12 weeks as part of the survival follow-up

Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after BIRC-confirmed RECIST 11-defined progressive disease and after meeting the eligibility criteria prior to crossover

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2020-001578-31 EUDRACT_NUMBER None None