Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04139317
Status:
TERMINATED
Last Update Posted:
2024-02-08
First Post:
2019-10-14
Brief Title:
Safety and Efficacy of Capmatinib INC280 Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1 50
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression 50 and have no EGFR mutation or ALK rearrangement Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects
Detailed Description:
This was a randomized open-label multicenter phase II study evaluating the efficacy and safety of capmatinib plus pembrolizumab in comparison to pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer NSCLC with programmed cell death ligand-1 PD-L1 expression 50 mesenchymal epithelial transition MET unselected epidermal growth factor receptor EGFR wild type and anaplastic lymphoma kinase ALK negative
All eligible subjects were randomized to one of the treatment arms in a 21 capmatinib plus pembrolizumab pembrolizumab alone ratio Participants in both treatment arms were to receive up to 35 cycles approximately 24 months of study treatment The study enrollment was halted on 21-Jan-2021 per sponsors decision The enrollment halt decision was based on lack of tolerability observed in the capmatinib plus pembrolizumab arm
Immediately following the enrollment halt the below procedural changes were performed
Capmatinib treatment was discontinued in subjects on the combination arm All ongoing subjects were allowed to continue receiving pembrolizumab single agent treatment as per investigators discretion until unacceptable toxicity or disease progression or up to 35 cycles of treatment whichever occurred first
Termination of capmatinib pharmacokinetics PK sample collection
Termination of pembrolizumab PKimmunogenicity IG sample collection After the enrollment halt the study protocol was amended amendment 03 and the collection of efficacy data was stopped As pembrolizumab is a registered and commercialized treatment for the study indication the efficacy and safety assessments were to be performed as per each institutions standard of care and no longer captured in the electronic Case Report Form eCRF except reporting of adverse events Additionally as single-agent pembrolizumab is a well-established standard treatment for the study indication the requirement for post-treatment disease progression follow-up and survival follow-up were removed
All eligible subjects were randomized to one of the treatment arms in a 21 capmatinib plus pembrolizumab pembrolizumab alone ratio Participants in both treatment arms were to receive up to 35 cycles approximately 24 months of study treatment The study enrollment was halted on 21-Jan-2021 per sponsors decision The enrollment halt decision was based on lack of tolerability observed in the capmatinib plus pembrolizumab arm
Immediately following the enrollment halt the below procedural changes were performed
Capmatinib treatment was discontinued in subjects on the combination arm All ongoing subjects were allowed to continue receiving pembrolizumab single agent treatment as per investigators discretion until unacceptable toxicity or disease progression or up to 35 cycles of treatment whichever occurred first
Termination of capmatinib pharmacokinetics PK sample collection
Termination of pembrolizumab PKimmunogenicity IG sample collection After the enrollment halt the study protocol was amended amendment 03 and the collection of efficacy data was stopped As pembrolizumab is a registered and commercialized treatment for the study indication the efficacy and safety assessments were to be performed as per each institutions standard of care and no longer captured in the electronic Case Report Form eCRF except reporting of adverse events Additionally as single-agent pembrolizumab is a well-established standard treatment for the study indication the requirement for post-treatment disease progression follow-up and survival follow-up were removed
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 |
|---|---|---|---|
| 2019-002660-27 | EUDRACT_NUMBER | None | None |