LOS ANGELES — The IMMUNO-BIOMAP clinical trial is open and recruiting patients with advanced non-small cell lung cancer. The Phase 2 study (NCT07288034) evaluates biomarkers that predict response to first-line PD(L)1-based immunotherapy and guide biomarker-directed second-line treatment after progression.
IMMUNO-BIOMAP (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) is sponsored by City of Hope Medical Center with support from the National Cancer Institute. The trial is led by principal investigators Ravi Salgia, MD, and Jyoti Malhotra, MD, at City of Hope.
Part I of the study enrolls patients with histologically confirmed stage IIIB or IV NSCLC who are beginning FDA-approved PD-1/PD-L1 therapy with or without chemotherapy. Participants provide blood samples for circulating tumor DNA (ctDNA) research and may undergo tumor biopsy, with imaging collected throughout treatment. The trial tests whether ctDNA and multi-omic biomarkers can predict early immunotherapy response and inform ctDNA-guided decisions on treatment duration after 12 to 24 months of first-line therapy.
Part II assigns patients who experience radiographic progression to biomarker-specific second-line regimens. Patients with STK11 or KEAP1 mutations receive tremelimumab plus durvalumab; patients with KRAS G12C mutations receive adagrasib plus bevacizumab. Additional arms may be added as new biomarker-directed options are validated. Exploratory analyses use ctDNA and tissue multi-omics for reverse translational modeling of immunotherapy resistance.
The trial aims to enroll approximately 535 participants across 13 U.S. sites, including City of Hope locations in Duarte, Irvine, Corona, Huntington Beach, and additional partner centers. Primary endpoints include progression-free survival during first-line treatment and biomarker-guided second-line progression-free survival compared with historical controls.
Eligible patients are adults aged 18 or older with stage IIIB or IV NSCLC, measurable disease by RECIST v1.1, ECOG performance status of 0–2, and no sensitizing EGFR mutation or ALK/ROS1 alteration. Patients scheduled to begin anti-PD-1/PD-L1 therapy, or who have received up to four prior cycles in the first-line setting, may qualify.
For more information about IMMUNO-BIOMAP, visit clinicaltrials.gov/study/NCT07288034 or contact City of Hope clinical trials at 855-970-2654.