Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03647488
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2018-08-20
Brief Title:
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative AdvancedMetastatic Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-01
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:
The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor EGFR wild type for exon 19 deletions and exon 21 L858R substitution mutations anaplastic lymphoma kinase ALK rearrangement negative in locally advanced stage IIIB not eligible for definitive chemo-radiation or metastatic stage IV Non-small cell lung cancer NSCLC after failure of platinum doublet and checkpoint inhibitor treatment
Detailed Description:
This was a two-part prospectively designed multicenter open-label randomized phase II study
Part 1 Run-in Prior to the randomized part of the study a run-in to assess the safety and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab combination was conducted Participants were treated with capmatinib 400 mg twice daily BID and spartalizumab 400 mg intravenously iv once every 28 days A review was planned to take place after all participants had at least 24 weeks of follow-up The decision to expand the study to the randomized part was to be based on the safety tolerability and preliminary efficacy of the capmatinib and spartalizumab combination
Part 2 Randomized Subjects were planned to be randomized to one of the following arms in a 21 ratio 1 combination of capmatinib 400 mg BID and spartalizumab 400 mg iv once every 28 days 2 docetaxel 75 mgm2 iv following local guidelines as per standard of care and product labels Based on the results obtained in the run-in part of the study the randomized part was not opened
For the run-in part of the study the treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression unacceptable toxicity withdrawal of informed consent pregnancy lost to follow-up or death irrespective of start of new anti-neoplastic therapy After treatment discontinuation all subjects were followed for safety evaluations during the safety follow-up period and the subjects status was collected every 8 weeks as part of the survival follow-up
Part 1 Run-in Prior to the randomized part of the study a run-in to assess the safety and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab combination was conducted Participants were treated with capmatinib 400 mg twice daily BID and spartalizumab 400 mg intravenously iv once every 28 days A review was planned to take place after all participants had at least 24 weeks of follow-up The decision to expand the study to the randomized part was to be based on the safety tolerability and preliminary efficacy of the capmatinib and spartalizumab combination
Part 2 Randomized Subjects were planned to be randomized to one of the following arms in a 21 ratio 1 combination of capmatinib 400 mg BID and spartalizumab 400 mg iv once every 28 days 2 docetaxel 75 mgm2 iv following local guidelines as per standard of care and product labels Based on the results obtained in the run-in part of the study the randomized part was not opened
For the run-in part of the study the treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression unacceptable toxicity withdrawal of informed consent pregnancy lost to follow-up or death irrespective of start of new anti-neoplastic therapy After treatment discontinuation all subjects were followed for safety evaluations during the safety follow-up period and the subjects status was collected every 8 weeks as part of the survival follow-up
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 |
|---|---|---|---|
| 2018-001420-19 | EUDRACT_NUMBER | None | None |