Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04323436
Status:
TERMINATED
Last Update Posted:
2024-02-06
First Post:
2020-03-23
Brief Title:
Study of Capmatinib and SpartalizumabPlacebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Double-blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of Capmatinib and Spartalizumab vs Capmatinib and Placebo as 1st Line Treatment for Advanced NSCLC Patients With MET exon14 Skipping Mutations
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study termination based on sponsor decision due to lack of tolerability observed with capmatinib and spartalizumab combination treatment when compared to data from capmatinib single agent studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind placebo controlled randomized phase II study evaluating the efficacy and safety of capmatinib INC280 and spartalizumab PDR001 combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer NSCLC patients with MET exon 14 skipping METΔex14 mutations
Detailed Description:
The purpose of this study was to evaluate the efficacy and safety of capmatinib in combination with spartalizumab in treatment naive patients with EGFR wild-type ALK rearrangement negative advanced NSCLC harboring METΔex14 mutations
A run-in part Part 1 was conducted to determine the anti-tumor activity and safety of capmatinib in combination with spartalizumab Upon review of safety data and confirmation of anti-tumor activity in Part 1 the randomized part Part 2 was planned to be initiated to compare the efficacy and safety of capmatinib plus spartalizumab to capmatinib plus placebo
Combined treatment of METΔex14 mutated NSCLC with capmatinib and spartalizumab was expected to result in improved efficacy compared to each single agent due to direct targeting of an oncogenic driver MET as well as more efficient stimulation of an anti-tumor immune response than with PD-1 blockade alone
The study enrollment was halted on 28-Jul-2021 per sponsors decision The enrollment halt decision was based on lack of tolerability observed in capmatinib and spartalizumab combination treatment in the run-in part Part 1 of the trial
Following the study enrollment halt during Part 1 Run in Part Part 2 was not initiated
Immediately following the enrollment halt
All ongoing subjects were discontinued from spartalizumab treatment and continue to receive single agent capmatinib
Enrolled subjects who had not started study treatment were to receive capmatinib single agent treatment from the start
A run-in part Part 1 was conducted to determine the anti-tumor activity and safety of capmatinib in combination with spartalizumab Upon review of safety data and confirmation of anti-tumor activity in Part 1 the randomized part Part 2 was planned to be initiated to compare the efficacy and safety of capmatinib plus spartalizumab to capmatinib plus placebo
Combined treatment of METΔex14 mutated NSCLC with capmatinib and spartalizumab was expected to result in improved efficacy compared to each single agent due to direct targeting of an oncogenic driver MET as well as more efficient stimulation of an anti-tumor immune response than with PD-1 blockade alone
The study enrollment was halted on 28-Jul-2021 per sponsors decision The enrollment halt decision was based on lack of tolerability observed in capmatinib and spartalizumab combination treatment in the run-in part Part 1 of the trial
Following the study enrollment halt during Part 1 Run in Part Part 2 was not initiated
Immediately following the enrollment halt
All ongoing subjects were discontinued from spartalizumab treatment and continue to receive single agent capmatinib
Enrolled subjects who had not started study treatment were to receive capmatinib single agent treatment from the start
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 |
|---|---|---|---|
| 2019-003097-11 | EUDRACT_NUMBER | None | None |