Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib

Sponsor
Jair Bar, M.D., Ph.D.
Study ID
NCT06206850
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-squamous NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Oral Osimertinib 80 mg once daily (QD) for the duration of 9 weeks (3 cycles).

Study Details

This study is a single-arm phase II study of neoadjuvant osimertinib as monotherapy for the treatment of patients with resectable stage II-III non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) sensitizing mutation (L858R or deletion in exon 19 \[Ex19del\]).

Key Dates

Start date
Feb 19, 2024
Status verified
Jan 2024
Primary completion
Jan 31, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: neoadjuvant osimertinib
    Osimertinib 80 mg QD

Primary Outcome Measure

Identification of mechanisms of resistance to EGFR in surgical specimens [ Time Frame: Up to approximately 5 years ]

Central Contacts