Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study

Sponsor
AstraZeneca
Study ID
NCT07295821
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
May 30, 2029
Completion
May 30, 2029

Study Design

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

Arms

  • Experimental: Osimertinib as Induction Therapy Prior to Radiotherapy and Maintenance
    80 mg Osimertinib QD

Primary Outcome Measure

PFS (Progression-Free Survival) [ Time Frame: Assessed from date of first dose to progression (up to a maximum of approximately 2 years) ]

Central Contacts

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