Immunotherapy Biomarkers for Lung Cancer Treatment (IMMUNO-BIOMAP Trial)
This study, called IMMUNO-BIOMAP, is looking at how certain markers in your body (biomarkers like ALK, EGFR, PD-L1, ROS1) can help doctors predict how well initial immunotherapy treatments (like Anti-PD-L1 Monoclonal Antibody or Anti-PD1 Monoclonal Antibody) will work for stage IIIB-IV non-small cell lung cancer. It also aims to help choose the best second-line treatments, which might include Adagrasib or Bevacizumab. You would receive standard immunotherapy and undergo tumor biopsies. The study hopes to improve how we select treatments to give you the best chance of slowing down cancer progression. This study is currently unclear on its recruitment status and plans to enroll 535 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 535 participants. It aims to develop biomarkers for predicting immunotherapy response and evaluate different treatment strategies.
- What's involved
- You would receive PD(L)1-based therapy, potentially with chemotherapy, for up to 12-24 months. You would also undergo tumor biopsy procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival (PFS) will be assessed for up to 3 years during both first-line and second-line treatments.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07288034
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~535 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:AdagrasibAnti-PD-L1 Monoclonal AntibodyAnti-PD1 Monoclonal AntibodyBevacizumabBiopsy ProcedureBiospecimen Collection
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) during first-line treatment (Part I)
Measured over From the start of randomization to disease progression or death from any cause, whichever occurs first, assessed up to 3 years
+1 more outcome measured
Conditions
Where it's being run
13 sites across 4 statesCalifornia10
Arizona1
Georgia1
Illinois1
Study leadership
- Ravi Salgia, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
- Jyoti Malhotra [Co-PI], MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative. (Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure compliance.)
Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR B) archival or new biopsy tissue available (to be sent to Tempus). Acceptable sample types include: two formalin-fixed paraffin-embedded (FFPE) tissue core biopsies, or two 25um sections of 5-10mm\^2 tissue, or 15-20 unstained slides at 10um thickness (a minimum of 10 unstained slides must be provided)
Agreement to blood collection for ctDNA research
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Histologically confirmed stage IIIB or IV NSCLC
Absence of sensitizing EGFR mutation or ALK/ROS1 alteration
Scheduled to begin treatment with a Food and Drug Administration (FDA) approved PD1/PDL1 antibody with or without chemotherapy. Participants who have already started treatment with anti-PD1/PDL1 in this setting may enroll if they have only received up to 4 cycles of treatment so far. Patients who have received PD1/PDL1 antibody for early-stage NSCLC are allowed to enroll if they completed the therapy at least 6 months before starting trial therapy
Measurable disease by RECIST version (v) 1.1
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
NOTE: Growth factor is not permitted within 14 days of ANC assessment
Platelets ≥ 100,000/mm\^3
NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
Hemoglobin ≥ 9g/dL
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
Alanine aminotransferase (ALT) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
If seropositive for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
PART II: Documented informed consent (for Part II) of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines
PART II: ECOG ≤ 2
PART II: Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
PART II: ANC ≥ 1,500/mm\^3
NOTE: Growth factor is not permitted within 14 days of ANC assessment
PART II: Platelets ≥ 100,000/mm\^3
NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
PART II: Hemoglobin ≥ 9g/dL
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
PART II: Total bilirubin ≤ 1.5 x ULN
PART II: AST ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
PART II: ALT ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
PART II: Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
Exclusion
Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Radiation therapy within 7 days prior to day 1 of protocol therapy
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association \[NYHA class\] ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs
Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable
Prior history of interstitial lung disease (ILD) or non-infectious pneumonitis requiring high-dose glucocorticoids
Active infection requiring antibiotics
Other active malignancy. Patients with concurrent malignancy other than non-melanoma skin cancer are not eligible for this trial due to potential confounding of the ctDNA results
Females only: Pregnant or breastfeeding
PART II: Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
PART II: Radiation therapy within 7 days prior to day 1 of protocol therapy
PART II ARM A ONLY: Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
PART II ARM A ONLY: Patients with prior history of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) treatment
PART II ARM B ONLY: Patients with prior history of KRAS G12C inhibitors
PART II: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
PART II ARM A ONLY: Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs
PART II ARM B ONLY: Grade ≥ 2 proteinuria as demonstrated by ≥ 2+ protein and ≥ 1.0 g of protein with 24-hour urine collection (patients found to have ≥ 2+ protein on dipstick urinalysis must have 24-hour urine collection and demonstrate \< 1g of protein in 24 hours in order to be eligible for treatment)
PART II: Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable
PART II: Clinically significant uncontrolled illness
PART II: Active infection requiring antibiotics
PART II: Other active malignancy
PART II FEMALES ONLY: Pregnant or breastfeeding
PART II: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
What this trial measures
- Progression-free survival (PFS) during first-line treatment (Part I)From the start of randomization to disease progression or death from any cause, whichever occurs first, assessed up to 3 years
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.
- PFS by arm for second-line treatment (Part II)From the start of treatment to disease progression or death from any cause, whichever occurs first, assessed up to 3 years
Will be estimated using the 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. DTR-specific PFS will also be estimated using IPW to account for multiple randomizations and treatment adaptations.