NCT04585477

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Objective: The primary objective of this study is to measure the change in ctDNA from trial enrollment to after 2 cycles of adjuvant durvalumab in subjects with stage I to III NSCLC who had positive ctDNA following definitive treatment with surgery or radiation and completion of adjuvant standard of care chemotherapy. Secondary Objectives 1. To compare disease free survival (DFS) 2. To compare overall survival (OS) 3. To evaluate the frequency and severity of toxicity 4. To evaluate the severity of toxicity

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-08
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2020-10-14
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study