Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05686434
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC, Stage I

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    This is a prospective, open, single-center, single-arm phase II clinical study with EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory，to evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).

Study Details

This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).

Key Dates

Start date
Oct 14, 2022
Status verified
Dec 2022
Primary completion
Oct 14, 2024
Completion
Oct 14, 2029

Study Design

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

Arms

  • Experimental: Osimertinib adjuvant therapy group
    Patients must be enrolled within 10 weeks of complete surgical excision and receive oral Osimertinib at a dose of 80 mg once a day for a planned duration of 3 years (156 weeks).

Primary Outcome Measure

3-year DFS rate [ Time Frame: From date of randomisation up to approximately 5 years ]

Central Contacts

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