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

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 8, 2021

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2026

Conditions
Non-small Cell Lung CancerNon-small Cell Lung Cancer Stage INon-small Cell Lung Cancer Stage IINon-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.

Trial Locations (1)

94305

RECRUITING

Stanford University, Stanford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Stanford University

OTHER