Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02414139
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2015-03-31
Brief Title:
Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type wt Advanced Non-small Cell Lung Cancer NSCLC Geometry Mono-1
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Multicenter Study of Oral MET Inhibitor INC280 in Adult Patients With EGFR Wild-type wt Advanced Non-small Cell Lung Cancer NSCLC Geometry Mono-1
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advancedmetastatic stage IIIB or IV non-small cell lung cancer NSCLC who had wild-type epidermal growth factor receptor EGFR wt for exon 19 deletions and exon 21 L858R substitution mutations anaplastic lymphoma kinase ALK-negative rearrangement and mesenchymal epithelial transition MET mutations leading to exon 14 deletion referred to as MET mutation hereafter andor MET amplification
Detailed Description:
This was a Phase II multicenter open-label study Patients were enrolled in different cohorts based on their MET status amplification andor mutation and prior treatment status Cohort 1a Cohort 1b Cohort 2 Cohort 3 Cohort 4 Cohort 5a Cohort 5b Cohort 6 and Cohort 7 MET mutation by RT-PCR andor MET amplification status by gene copy number GCN by FISH was determined by central laboratory
Patients in Cohorts 1 2 3 and 4 had previously failed 1 or 2 prior lines of systemic therapy while patients enrolled in Cohorts 5 and 7 were treatment-naïve for advanced diseasemetastatic disease Patients enrolled in Cohort 6 had failed 1 prior line of systemic therapy for advanced metastatic disease
Patients with MET mutation were enrolled in Cohort 4 pre-treated Cohort 5b treatment naïve or Cohort 7 treatment naïve expansion cohort of Cohort 5b irrespective of their MET GCN The enrollment in expansion Cohort 7 started after the completion of enrollment in Cohort 5b
Patients without MET mutation were enrolled in Cohorts 1a 1b 2 3 pre-treated or 5a treatment naïve based on their MET GCN Patients enrolled in Cohort 6 expansion cohort of Cohort 1a and Cohort 4 had either MET GCN 10 without MET mutation Cohort 61 or MET mutation irrespective to their MET GCN Cohort 62 The enrollment in Cohort 6 started upon enrollment completion of the respective Cohort 1a or Cohort 4
All participants in the study received oral capmatinib 400 mg twice daily A treatment cycle was defined as 21 days Treatment with capmatinib continued until patient experienced any of the following disease progression according to RECIST 11 as determined by investigator and confirmed by Blinded Independent Review Committee BIRC unacceptable toxicity that precluded further treatment treatment discontinuation at the discretion of the Investigator or patient lost to follow-up or death Treatment with capmatinib was allowed beyond RECIST 11-defined disease progression as determined by investigator and confirmed by BIRC if in the judgment of the investigator there was evidence of clinical benefit and the patient wished to continue on the study treatment All patients continued to have safety evaluations for 30 days after the last dose of study treatment
Patients who discontinued treatment with capmatinib for any reason other than disease progression as determined by the investigator and confirmed by BIRC death withdrawal of consent for further assessments or being lost to follow-up continued to have tumor assessments post-treatment efficacy follow-up until disease progression confirmed by BIRC death withdrawal of consent for further assessments or lost to follow-up
All patients who discontinued treatment with capmatinib were followed for survival post-treatment survival follow-up until death loss to follow-up withdrawal of consent to survival follow-up or the end of the study
Patients in Cohorts 1 2 3 and 4 had previously failed 1 or 2 prior lines of systemic therapy while patients enrolled in Cohorts 5 and 7 were treatment-naïve for advanced diseasemetastatic disease Patients enrolled in Cohort 6 had failed 1 prior line of systemic therapy for advanced metastatic disease
Patients with MET mutation were enrolled in Cohort 4 pre-treated Cohort 5b treatment naïve or Cohort 7 treatment naïve expansion cohort of Cohort 5b irrespective of their MET GCN The enrollment in expansion Cohort 7 started after the completion of enrollment in Cohort 5b
Patients without MET mutation were enrolled in Cohorts 1a 1b 2 3 pre-treated or 5a treatment naïve based on their MET GCN Patients enrolled in Cohort 6 expansion cohort of Cohort 1a and Cohort 4 had either MET GCN 10 without MET mutation Cohort 61 or MET mutation irrespective to their MET GCN Cohort 62 The enrollment in Cohort 6 started upon enrollment completion of the respective Cohort 1a or Cohort 4
All participants in the study received oral capmatinib 400 mg twice daily A treatment cycle was defined as 21 days Treatment with capmatinib continued until patient experienced any of the following disease progression according to RECIST 11 as determined by investigator and confirmed by Blinded Independent Review Committee BIRC unacceptable toxicity that precluded further treatment treatment discontinuation at the discretion of the Investigator or patient lost to follow-up or death Treatment with capmatinib was allowed beyond RECIST 11-defined disease progression as determined by investigator and confirmed by BIRC if in the judgment of the investigator there was evidence of clinical benefit and the patient wished to continue on the study treatment All patients continued to have safety evaluations for 30 days after the last dose of study treatment
Patients who discontinued treatment with capmatinib for any reason other than disease progression as determined by the investigator and confirmed by BIRC death withdrawal of consent for further assessments or being lost to follow-up continued to have tumor assessments post-treatment efficacy follow-up until disease progression confirmed by BIRC death withdrawal of consent for further assessments or lost to follow-up
All patients who discontinued treatment with capmatinib were followed for survival post-treatment survival follow-up until death loss to follow-up withdrawal of consent to survival follow-up or the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2014-003850-15 | EUDRACT_NUMBER | None | None |