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

NCT05686434 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-01-17

No results posted yet for this study

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).

Conditions

  • NSCLC, Stage I

Interventions

DRUG

Osimertinib

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).

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Dongsheng Yue · Tianjin Medical University Cancer Institute and Hospital

  • Richeng Jiang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2024-10-14
Completion
2029-10-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686434 on ClinicalTrials.gov