Actively Recruiting
DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC
Led by University of Alabama at Birmingham · Updated on 2025-09-03
24
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment.
CONDITIONS
Official Title
DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form is provided.
- Willingness to follow all study procedures and availability for the entire study duration.
- Male or female aged 18 years or older.
- Histologically or cytologically confirmed stage IV non-small cell lung cancer.
- No known sensitizing mutations with approved first-line targeted therapy for NSCLC (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, MET).
- No prior systemic anticancer therapy for advanced or metastatic disease, except up to one cycle of chemotherapy while awaiting test results.
- Measurable disease based on RECIST 1.1 criteria.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Tumor tissue available from non-radiated sites with PD-L1 status less than 1% or negative.
- Circulating tumor DNA detected at baseline.
- Treated and stable central nervous system metastases with stable neurological status and low corticosteroid use.
- Adequate organ function for safe treatment per FDA-approved guidelines.
- For females of reproductive potential: negative pregnancy test within 72 hours before first study dose and willingness to use contraception during and after study.
- For males of reproductive potential: use of effective contraception during and after study.
You will not qualify if you...
- Participation in another investigational study or receipt of investigational therapy within 4 weeks before study treatment.
- Receipt of live-virus vaccination within 30 days before treatment start (non-live flu vaccines allowed).
- Active gastrointestinal conditions such as diverticulitis, abscess, obstruction, or carcinomatosis.
- Prior allergy or hypersensitivity to checkpoint inhibitors or related drugs.
- Known sensitivity to cisplatin, carboplatin, paclitaxel, or pemetrexed.
- Carcinomatous meningitis.
- Active or suspected autoimmune diseases except specified controlled conditions.
- Systemic corticosteroid or immunosuppressive medication use within 14 days before enrollment with exceptions.
- History or suspicion of interstitial lung disease or pneumonitis.
- Positive tests for HIV, Hepatitis B or C unless well-controlled without immunosuppression risk.
- History of other malignancies except certain skin cancers, carcinoma in situ treated curatively, and those in remission for over two years.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
A
Aakash Desai, MD, MPH
CONTACT
M
Margaret Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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