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NCT07288034 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial
A Phase 2 study, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 535
- Enrollment target
NCT07288034 is a Phase 2 study that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 535 participants.
The verdict
NCT07288034, a Phase 2 study, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 535 participants
- Enrollment target
Study Summary
This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD\[L\]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies,
Interventions
- PROCEDURE Biopsy Procedure
- DRUG Adagrasib
- BIOLOGICAL Bevacizumab
- BIOLOGICAL Anti-PD-L1 Monoclonal Antibody
- BIOLOGICAL Anti-PD1 Monoclonal Antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 535 participants |
| Start Date | 2026-04-08 |
| Est. Completion | 2028-10-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07288034
The ClinicalTrials.gov registry entry for NCT07288034 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biopsy Procedure is the first listed.
NCT07288034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07288034 about?
NCT07288034 is a clinical study titled "Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial". This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD\[L\]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stag...
What is the current status of trial NCT07288034?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 535 participants. The study started on 2026-04-08. Estimated completion is 2028-10-08.
What interventions are being tested in trial NCT07288034?
The interventions under investigation include: Biopsy Procedure (PROCEDURE), Adagrasib (DRUG), Bevacizumab (BIOLOGICAL), Anti-PD-L1 Monoclonal Antibody (BIOLOGICAL), Anti-PD1 Monoclonal Antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT07288034?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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