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

NCT04585477 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-10

No results posted yet for this study

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.

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

Interventions

DEVICE

AVENIO ctDNA Surveillance Kit

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

DRUG

Durvalumab

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.

DRUG

Durvalumab (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.

Sponsors & Collaborators

Principal Investigators

  • Joel W Neal, MD,PhD · Stanford Universiy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585477 on ClinicalTrials.gov