Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 8:52 PM
Study NCT ID:
NCT04163432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
A Randomized, Phase II Study of Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed and Carboplatin (PC) for Metastatic Non-Squamous NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
STAGGER
Brief Summary:
This is a Phase II, open label, randomized study of durvalumab in combination with pemetrexed and carboplatin in eligible adult patients with locally advanced or metastatic non-small cell lung cancer. The study will focus on the efficacy of two alternative staggered dosing regimens.
Detailed Description:
This trial will evaluated two different schedules of concurrent chemoimmunotherapy while simultaneously measuring immune activation, immune resistance and host factors. Both arms will consist of concurrent chemoimmunotherapy with durvalumab, pemetrexed and carboplatin, but in arm 1 the chemotherapy will precede the immunotherapy by a week and in arm 2 the immunotherapy will precede the chemotherapy by a week. Staggering these therapies still allows concurrent administration while allowing some degree of temporal isolation to better understand the contributions by chemotherapy and immunotherapy in this setting. Host and laboratory factors will be measured during treatment. We hypothesize that staggered dosing of immunotherapy in combination with chemotherapy can improve clinical benefit.
Study Oversight
Has Oversight DMC:
True
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?: