Actively Recruiting
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
Led by Hackensack Meridian Health · Updated on 2026-02-18
108
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
Sponsors
H
Hackensack Meridian Health
Lead Sponsor
M
MedSIR
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
CONDITIONS
Official Title
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, previously untreated Stage IV NSCLC
- Positive PD-L1 expression of at least 1% by immunohistochemistry
- Baseline Guardant360 CDx test completed before enrollment
- Willing to undergo serial ctDNA testing as required
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Measurable disease not previously irradiated
- Prior palliative radiotherapy completed at least 2 weeks before randomization
- ECOG Performance Score of 0 to 2
- Adequate organ function including hemoglobin above 9 g/dL and platelets above 100,000/mm3
- Liver enzymes within specified limits depending on liver metastases status
- Absolute neutrophil count above 1500 cells/mm3
- Creatinine within acceptable range or kidney function adequate
- Willingness to use effective contraception if of child-bearing potential or partner is female of child-bearing potential
You will not qualify if you...
- Under age 18
- Unable to provide informed consent
- Presence of EGFR, ALK, ROS1, MET, or RET oncogenic driver mutations with approved first-line targeted therapies
- No detectable ctDNA or ctDNA variant allele fraction 0.3% or less at baseline
- Untreated central nervous system metastases
- Carcinomatous meningitis
- Not recovered from major surgery or significant injury within 14 days
- Previous malignancies except certain non-melanoma or in situ cancers unless remission for at least 2 years
- Other active malignancies requiring treatment
- Active, known, or suspected autoimmune disease requiring systemic treatment
- Use of systemic corticosteroids or immunosuppressants within 14 days before randomization
- Symptomatic interstitial lung disease
- Significant uncontrolled cardiovascular disease including uncontrolled hypertension, recent angina, recent heart attack, long QT syndrome, serious arrhythmias, uncontrolled heart failure, or myocarditis
- Medical conditions increasing risk or interfering with safety assessment
- Positive test for active hepatitis B or C infection
- Grade 2 or higher peripheral neuropathy
- Life expectancy less than 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
2
John Theurer Cancer Center, Hackensack Meridian Health
Hackensack, New Jersey, United States, 07410
Actively Recruiting
3
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Not Yet Recruiting
Research Team
L
Lauren Finaldi
CONTACT
S
Suzanne Kosky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here