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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: Recruiting Phase 2 study, sponsored by City of Hope Medical Center.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.
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,
Primary Outcome
Will be estimated using the Kaplan-Meier (KM) method. Comparisons across treatment arms will be performed using stratified log-rank tests and Cox proportional hazards models, with assessment of the proportional-hazards assumption and exploration of time-dependent hazard ratios. Dynamic treatment regimen (DTR)-specific PFS will also be estimated using inverse probability weighting (IPW) to account for multiple randomizations and treatment adaptations.
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 |
What NCT07288034 shows while recruiting
NCT07288034 is an interventional study that assigns participants to a tested intervention. The registered 535 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (302% higher).
The record links to 0 conditions, and to 5 interventions - of which Biopsy Procedure is the first listed.
NCT07288034 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07288034's enrollment target sits among peer trials
535 63rd of 2000 higher than 1,938 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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