Actively Recruiting
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage Non-Small Cell Lung Cancer (ADAPT-E)
Led by Stanford University · Updated on 2026-02-10
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether circulating tumor DNA (ctDNA) blood testing can help detect leftover blood cancer in people with early-stage non-small cell lung cancer (NSCLC). The study aims to find out if the amount of cancer cells found in the blood can be lowered by giving durvalumab after standard treatment in those who test positive for residual cancer. This is a Phase 2 study focusing on patients with stage I to III NSCLC who have completed surgery, radiation, and chemotherapy. Participants with detectable ctDNA will receive durvalumab through an intravenous injection of 1500 mg every 28 days for up to 12 months, starting with 2 cycles followed by assessment of ctDNA levels. If no cancer progression or toxicity occurs, treatment continues up to about 12 cycles total. Those without detectable ctDNA will follow standard care without additional treatment. The study also involves monitoring for progression-free and overall survival. During the study, participants will undergo blood tests to measure ctDNA levels at enrollment and after 8 weeks of durvalumab treatment. Researchers will evaluate changes in ctDNA, disease-free survival, overall survival, and side effects over 12 months. Participants will be closely monitored for treatment safety and effectiveness throughout the trial, which started in April 2021 and is expected to run until December 2026.
CONDITIONS
Brief Title
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed non-small cell lung cancer without small cell components
- Adenocarcinoma patients negative for certain EGFR mutations and ALK or ROS1 rearrangements
- Clinical or pathological stage IA2 to IIIC NSCLC or locoregionally recurrent disease
- Completed curative surgery and/or radiation therapy, may have had chemotherapy
- No more than 32 weeks since last therapy
- No known residual or recurrent disease after treatment
- Available pre-treatment tumor tissue or DNA samples
- No prior immunotherapy except study treatment
- No investigational anti-cancer drugs within 4 weeks before enrollment
- Age 18 years or older
- ECOG Performance Status 0 or 1
- Life expectancy of 12 weeks or more
- Acceptable blood counts and laboratory values
- Ability and willingness to provide informed consent
- Use of effective contraception during and 8 months after study
- Body weight greater than 30 kg
You will not qualify if you...
- Involvement in study planning or conduct
- History of severe pneumonitis from prior radiation (grade 3 or higher)
- Active treatment for another primary cancer, except certain endocrine therapies
- Need for ongoing systemic immunosuppressive medication
- Unresolved toxicities above grade 2 from prior therapies except specific exceptions
- Active or prior autoimmune or inflammatory disorders affecting treatment eligibility
- History of primary immunodeficiency or organ transplant needing immunosuppression
- Active infections including hepatitis B, hepatitis C, tuberculosis, or HIV
- Receipt of live vaccines within 30 days before enrollment
- Uncontrolled illnesses like heart failure, hypertension, angina, arrhythmia, interstitial lung disease, or serious gastrointestinal conditions
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding females
- Other medical conditions deemed unsuitable by the investigator
- Lack of effective birth control in subjects of reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants with detectable ctDNA (MRD+) receive durvalumab intravenously every 4 weeks for up to 12 months. ctDNA levels are re-checked after 2 cycles to assess response. Subjects without detectable ctDNA (MRD-) receive standard of care without additional treatment.
Monthly visits for up to 12 months
Duration - Up to 12 months after treatment
Participants are monitored for disease progression, overall survival, and adverse events after completing treatment.
Visits as needed for monitoring
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
L
Laura Lundi, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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