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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04585477
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-small Cell Lung Cancer
  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II
  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AVENIO ctDNA Surveillance Kit — DEVICE
    Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
  • Durvalumab — DRUG
    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.
  • Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 8, 2021
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 minimal residue disease positive(MRD+)
    Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS).
  • Active Comparator: Cohort 2 minimal residue disease negative (MRD-)
    Subjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment

Primary Outcome Measure

Decrease in ctDNA Level [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Laura Lundi
[email protected]
650-723-1002
Joel W Neal, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Stanford University· Stanford, CA

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