Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Recruiting
Phase 2
Interventional Study
NSCLC, Stage I
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 65 (estimated)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital · Other
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About This Trial
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 airwa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The subject will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
2. Male and female, ≥18 years old;
3. Primary non-squamous NSCLC confirmed histologically by the central laboratory;
4. Brain imaging exami…
Contacts