RecruitingPhase 2NCT05686434

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

Efficacy and Safety of Osimertinib Adjuvant Therapy in High-risk Stage I EGFRm NSCLC After Complete Resection(OSTAR): a Prospective, Single-arm Study

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

65 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

NSCLC, Stage I

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (OSTAR) tests whether osimertinib — a targeted cancer drug — can prevent lung cancer from coming back in patients who have had surgery to remove early-stage (Stage I) non-small cell lung cancer that carries a specific genetic change called an EGFR mutation. **You may be eligible if...** - You are 18 or older - You have non-squamous non-small cell lung cancer (NSCLC) confirmed by biopsy - Your tumor has a common EGFR mutation (exon 19 deletion or L858R) - Your cancer was completely removed by surgery, with no remaining cancer cells at the edges - Your surgery was within the last 10 weeks - Your tumor had certain high-risk features (such as solid or micropapillary components) - You are in good general health (WHO performance score 0–1) **You may NOT be eligible if...** - Your cancer has spread beyond the lung (not Stage I) - Your surgical margins were positive (cancer cells remained after surgery) - Your tumor does not have the required EGFR mutations - Your brain has not been imaged before enrollment - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib

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).