Actively Recruiting
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Led by Stanford University · Updated on 2026-02-10
80
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.
CONDITIONS
Official 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 (NSCLC) without small cell components
- Adenocarcinoma patients must not have specific EGFR mutations or ALK/ROS1 rearrangements
- Clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease
- Completed curative therapy with surgery and/or radiation, may have had chemotherapy
- No more than 32 weeks have passed since last therapy
- No known residual or recurrent disease after therapy
- Pre-treatment tumor tissue or DNA available for analysis
- No prior or planned immunotherapy except this study
- No investigational anti-cancer drugs within 4 weeks before enrollment
- Age 18 years or older
- ECOG performance status 0 or 1
- Life expectancy at least 12 weeks
- Adequate laboratory values for neutrophils, platelets, hemoglobin, kidney and liver function
- Willingness to sign informed consent
- Use of effective contraception from enrollment until 8 months after study therapy
- Body weight over 30 kg
You will not qualify if you...
- Involvement in planning or conduct of the study
- History of grade 3 or higher pneumonitis from prior radiation
- Active treatment for another primary cancer except endocrine therapy for breast or prostate cancer
- Need for ongoing chronic systemic immunosuppressive medication (with some exceptions)
- Unresolved toxicity greater than grade 2 from prior therapy (some exceptions apply)
- Active or prior autoimmune or inflammatory disorders limiting durvalumab use
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Active infections including significant infections, hepatitis B or C, tuberculosis, or HIV
- Receipt of live vaccine within 30 days before enrollment
- Uncontrolled serious medical conditions including heart failure, hypertension, angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric illness
- Pregnant or breastfeeding females
- Any other medical condition making participation unsuitable
- Not agreeing to use effective birth control if of reproductive potential (any gender)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
L
Laura Lundi, BS
CONTACT
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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