Actively Recruiting
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Led by Sun Yat-sen University · Updated on 2024-01-16
30
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer
CONDITIONS
Official Title
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed N2 positive non-squamous NSCLC with resectable Stage IIIA or T3-4N2 IIIB disease
- Complete surgical resection of the primary tumor is considered achievable by a multidisciplinary team including a thoracic surgeon
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment without worsening in the prior 2 weeks
- Tumor harbors common EGFR mutations associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or with other EGFR mutations
You will not qualify if you...
- History of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid treatment, or active ILD
- History of other primary malignancies except those treated with curative intent and inactive for 2 or more years, adequately treated non-melanoma skin cancer, lentigo malignancy, or carcinoma in situ without evidence of disease
- Prior pre-operative radiotherapy
- Mixed small cell and non-small cell lung cancer histology
- T4 tumors invading major structures or bulky unresectable N2 disease
- Candidates only for segmentectomy or wedge resection
- Previous systemic anti-cancer therapy for NSCLC including chemotherapy, biologics, immunotherapy, or investigational drugs
- Previous treatment with EGFR-TKI therapy
- Current use of strong CYP3A4 inducers or inability to stop such medications/herbal supplements before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang, Ph.D.,M.D.
CONTACT
J
Jiyang Chen, Ph.D.,M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here