RecruitingPhase 2NCT04585477

Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)


Sponsor

Stanford University

Enrollment

80 participants

Start Date

Apr 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects tumor DNA (called ctDNA) to guide whether people who have had treatment for early-stage non-small cell lung cancer (NSCLC) need additional therapy. If ctDNA is detected after treatment, it may mean the cancer is still present, and the study will test whether adding immunotherapy helps. **You may be eligible if...** - You are 18 years old or older and have been diagnosed with NSCLC (stage IA2–IIIC) - You have completed all intended treatment (surgery and/or radiation, with or without chemotherapy) - No more than 32 weeks have passed since completing treatment - There is no currently detectable cancer on imaging - You have not received and are not planned to receive immunotherapy outside this study - Your blood counts and organ function are in acceptable range **You may NOT be eligible if...** - You have a specific EGFR, ALK, or ROS1 mutation (if adenocarcinoma subtype) - You have small cell lung cancer component - You have received immunotherapy before - You have known residual or recurrent disease after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAVENIO ctDNA Surveillance Kit

Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)

DRUGDurvalumab

Participants in the intervention arm will receive Durvalumab (1500 mg IV every 4 weeks for up to 12 months) as monotherapy or 20mg/kg if weight is 30kg or less.

DRUGDurvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy

Participants in the intervention arm (Cohort 1 MRD+) will receive a fixed dose of Durvalumab (1500 mg IV every 4 weeks for up to 12 months), either as monotherapy or in combination with a platinum-based chemotherapy regimen (investigator's choice). Platinum-based chemotherapy options include carboplatin, cisplatin, pemetrexed, paclitaxel, or nab-paclitaxel, administered per standard of care for up to 4 cycles.


Locations(1)

Stanford University

Stanford, California, United States

View Full Details on ClinicalTrials.gov

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NCT04585477


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