Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04093167
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2019-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CTDNA Response Adaptive Immuno-Chemotherapy in NSCLC
Sponsor:
Canadian Cancer Trials Group
Organization:
Study Overview
Official Title:
A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung Cancer
Status:
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:
None
Brief Summary:
BR36 will evaluate the potential clinical benefit of tailoring immunotherapy treatment based on ctDNA molecular response in non-small cell lung cancer.
Detailed Description:
BR36 is an international multi-centre, open-label, biomarker-directed, phase II/III trial of ctDNA response adaptive immuno-chemotherapy in patients with immune checkpoint and chemotherapy naïve metastatic non-small cell lung cancer with ≥50% PD-L1 TPS expression. This trial will test if adding chemotherapy to pembrolizumab for patients with persistent ctDNA on Liquid Biopsy drawn at 6 weeks of treatment will result in better progression-free and overall survival compared to patients who remain on pembrolizumab therapy until clinical progression with subsequent change in standard therapy.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CRI-CCTG-002 | OTHER | CRI | View |