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Recruiting Phase 2 NCT04585477

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

Trial Parameters

Condition Non-small Cell Lung Cancer
Sponsor Stanford University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-04-08
Completion 2026-12-30
Interventions
AVENIO ctDNA Surveillance KitDurvalumabDurvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy

Brief 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 Criteria

Inclusion Criteria 1. Pathologically (histologically or cytologically proven) NSCLC. Tumors with any component of small cell lung cancer are not allowed. Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R mutation, or ALK or ROS1 rearrangement. 2. AJCC 8th edition clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease. Stage IA1 tumors are excluded unless recurrent with radiographic solid component -or- pathologic invasive component of \> 10 mm. 3. Received curative intent therapy with surgery and/or radiation. Note: May have received chemotherapy. 4. Completed all intended therapy (surgery, radiation, and/or chemotherapy) - AND- no more than 32 weeks has elapsed after the last day of this therapy. 5. No known current radiographic or pathologic residual/recurrent disease (in the investigator's opinion) after completion of all intended therapy (for example, positive margins after surgery without adjuvant radiotherapy, or unequivocal r

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