Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2026-04-15
535
Participants Needed
13
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and/or effective in treating patients with stage IIIB/IV NSCLC with specific genetic mutations.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent or have a caretaker to ensure compliance
- Have molecular testing results from HopeSeq or Tempus within 3 months before enrollment or have archival/new biopsy tissue available
- Agree to blood collection for circulating tumor DNA (ctDNA) research
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
- No sensitizing EGFR mutation or ALK/ROS1 gene alterations
- Scheduled to start FDA-approved PD1/PDL1 antibody treatment with or without chemotherapy, or have received up to 4 cycles if already started
- Measurable disease by RECIST version 1.1 criteria
- Adequate blood counts: absolute neutrophil count ≥ 1,500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 9 g/dL
- Liver function within specified limits: total bilirubin ≤ 1.5x upper limit of normal (ULN), AST and ALT ≤ 3x ULN (up to 5x if liver metastases)
- Creatinine clearance ≥ 50 mL/min
- If positive for HIV, hepatitis B or C, viral load must be undetectable and on effective treatment
- Women of childbearing potential must have a negative pregnancy test
- Agreement to use effective birth control or abstain during the study and for 3 months after last dose
- For Part II: consent and ECOG ≤ 2; recovered from prior therapy toxic effects to grade 1 or less except alopecia; similar lab and organ function criteria as Part I
You will not qualify if you...
- Surgery within 4 weeks before starting study treatment, except minor procedures like port placement
- Need for systemic corticosteroids over 10 mg prednisone daily or other immunosuppressive drugs within specified timeframes before treatment
- Radiation therapy within 7 days before starting protocol therapy
- Active cardiovascular disease such as recent stroke, heart attack, unstable angina, severe heart failure, or serious arrhythmia
- Active or recent autoimmune disease requiring systemic treatment within 2 years
- Symptomatic central nervous system metastases or leptomeningeal carcinomatosis except stable and asymptomatic treated or untreated brain metastases
- History of interstitial lung disease or non-infectious pneumonitis requiring high-dose steroids
- Active infection requiring antibiotics
- Other active cancers except non-melanoma skin cancer
- Pregnant or breastfeeding females
- For Part II Arm A: prior CTLA-4 treatment or active autoimmune disease
- For Part II Arm B: prior treatment with KRAS G12C inhibitors or significant proteinuria
- Clinically significant uncontrolled illness or any other condition judged unsafe by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
City of Hope Corona
Corona, California, United States, 92882
Actively Recruiting
3
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
4
City of Hope Seacliff
Huntington Beach, California, United States, 92648
Actively Recruiting
5
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
6
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
7
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
8
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States, 92660
Actively Recruiting
9
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
10
City of Hope South Bay
Torrance, California, United States, 90503
Actively Recruiting
11
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
12
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Actively Recruiting
13
City of Hope at Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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