Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03386929
Status:
TERMINATED
Last Update Posted:
2023-12-18
First Post:
2017-12-14
Brief Title:
Survival Prolongation by Rationale Innovative Genomics
Sponsor:
Worldwide Innovative Network Association
Organization:
Worldwide Innovative Network Association
Study Overview
Official Title:
A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in AdvancedMetastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRING
Brief Summary:
Patients with advancedmetastatic non-small cell lung cancer NSCLC with no documented targetable alterations Epidermal Growth Factor Receptor EGFR mutation Anaplastic Lymphoma Kinase ALK translocation ROS1 mutation if available or MET exon 14 skipping mutation if available will receive a tri-therapy associating avelumab axitinib and palbociclib
Detailed Description:
During the Phase 1 approximately 30 patients the tri-therapy will be tested at different doses following a specific dose-escalation scheme 3 3 model in order to establish the safety and identify the Maximum Tolerated Dose MTD and recommended dose for the Phase 2 RP2D The phase 2 will confirm the safety and will assess the clinical utility of the tri-therapy approach in the treatment of advancedmetastatic NSCLC 100 patients The study will also explore the clinical utility of the Simplified Interventional Mapping System SIMS a new toolalgorithm enabling matching of NSCLC patients with combination therapy For this purpose tumormetastasis and matched normal tissue biopsies will be requested in order to obtain sequencing and expression profiles
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 |
|---|---|---|---|
| 2017-001455-32 | EUDRACT_NUMBER | None | None |