Ravi Salgia, MD, PhD, Discusses the ADAPT-Funded IMMUNO-BIOMAP Trial in NSCLC

City of Hope has opened enrollment for IMMUNO-BIOMAP (NCT07288034), a national, ARPA-H–funded phase 2 trial designed to identify biomarkers that predict which patients with metastatic non–small cell lung cancer (NSCLC) will respond to first-line immunotherapy.^1,2 The trial aims to enroll 535 patients over 6 years and will use biomarker data, including circulating tumor DNA (ctDNA), to guide treatment duration and inform second-line therapy selection as a patient's tumor evolves on treatment.

The trial is supported by an award of up to $23.7 million from the Advanced Research Projects Agency for Health (ARPA-H), part of the agency's $142 million Advanced Analysis for Precision Cancer Therapy (ADAPT) program. City of Hope is the only institution to receive ARPA-H funding for lung cancer research under ADAPT, which also funds parallel biomarker-driven trials in breast cancer and colorectal cancer at other institutions.

Ravi Salgia, MD, PhD, the Arthur & Rosalie Kaplan Chair in Medical Oncology and professor and chair of the Department of Medical Oncology & Therapeutics Research at City of Hope, is a lead investigator on the trial. Targeted Oncology^TM spoke with Salgia about the unmet need IMMUNO-BIOMAP addresses, its objectives, and what a positive read-out could mean for patients with NSCLC.

Targeted Oncology: What was the clinical gap that prompted this trial?

Ravi Salgia, MD, PhD: This is an ADAPT trial, and the clinical gap is really in the context of NSCLC, which is a very heterogeneous disease. For metastatic disease, you can have an EGFR mutation, an ALK fusion, or a ROS1 fusion, but there's a large population that doesn't have a targetable mutation—patients for whom, say, tyrosine kinase inhibitors aren't available. For those patients, immunotherapy is available, and that's where the biggest gaps are. How does immunotherapy work? Do you have to give it for 2 years? Can you decrease the amount given, in terms of time? And certainly, what biomarkers do we need to identify which patients will respond and which won't? As we know, in metastatic NSCLC we want to cure the disease, not just control it—can we make a huge impact there? Those are the big gaps we've identified, not just us, but the whole country and the whole world.

What are the trial's goals, and what specific biomarkers or tumor changes are you looking at?

This is really a biomarker-driven trial. Patients get immunotherapy either by itself or with chemotherapy, and it has to be first-line therapy. We have co-primary objectives. The first, in part 1, is to develop biomarkers that predict first-line treatment failure with immunotherapy. The second is to evaluate different treatment-duration strategies—based on cell-free DNA and ctDNA—for patients who don't have early treatment failure. The third, in part 2, is to evaluate second-line progression-free survival [PFS] for biomarker-specific treatment decisions compared with historical controls.

We also have a considerable number of secondary objectives. We want to evaluate how different ctDNA-guided treatment decisions affect overall survival by treatment arm; summarize the relationship between ctDNA changes and RECIST version 1.1 response throughout the trial; describe the incidence and severity of adverse events by treatment arm; and demonstrate the feasibility of an adaptive design that employs both dynamic treatment regimens and biomarker-specific directed therapies.

Looking ahead, what would a positive read-out of this trial look like, and what would that mean for clinical practice?

We want to revolutionize clinical practice. We know immunotherapy works for a certain subset of patients, but not all of them, and we want it to work for as many patients as we can. We want to know what it takes to predict who's going to respond, who's not, and who's going to have an early treatment failure—and how we can help our patients survive for a long time. PFS is a good end point, but ultimately, from a trial perspective and beyond, what I care about is overall survival for our patients, and how we can predict that. We also have to think about toxicities related to immunotherapy as we build these trials and come to conclusions.

What do you want your oncology colleagues to know about this trial?

We're thankful to the ARPA-H team for believing in this trial. It's an evolutionary trial because we want predictive biomarkers to become central to our decision-making. What we'd love is for our colleagues to consider enrolling patients. City of Hope is a national brand now—we have about 35 sites here in Southern California, and we also have locations in Chicago, Atlanta, and Phoenix. If colleagues have patients with stage IV disease who are starting on immunotherapy and don't have an actionable mutation like EGFR, ALK, or ROS1, we'd love to consider them for this trial and see those patients right away. My colleagues and I are available throughout California, as well as in Chicago, Atlanta, and Phoenix, to talk through whether a patient could enroll.

This trial is for lung cancer, but the ADAPT program also has trials for breast cancer and colon cancer, and we're really synergizing biomarkers to figure out what's common across those 3 diseases vs what's specific to lung cancer. I like this synergistic approach between institutions, thought leaders, and the government, all coming together to truly answer these questions in metastatic solid tumors. We really need to develop and deliver on that.

We have to invest in research. We didn't come this far without research—without it, we'd still be stuck in a different paradigm. We have to invest in research to make sure we can deliver for our nation, and for the world, and for our patients with any type of cancer. Research, research, research will really help us get there for our patients and their families.

REFERENCES

1. City of Hope opens national lung cancer clinical trial seeking to predict immunotherapy success. News release. City of Hope. July 21, 2026. Accessed August 10, 2026. https://tinyurl.com/33mwce43

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. ClinicalTrials.gov. Accessed August 10, 2026. https://clinicaltrials.gov/study/NCT07288034