Actively Recruiting
Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2024-05-09
51
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and feasibility of neoadjuvant osimertinib treatment in patients with resectable stage II-IIIB lung squamous cell carcinoma who have EGFR mutations. This research addresses a gap as previous trials focused less on this rare lung cancer subtype. The study is a phase 2 trial conducted by The First Affiliated Hospital of Guangzhou Medical University, aiming to understand how well this targeted therapy works before surgery. Patients enrolled in this trial will receive osimertinib orally at a dose of 80 mg daily for at least 9 weeks before surgery. This neoadjuvant treatment aims to reduce tumor size and improve surgical outcomes. The trial is a single-arm study, meaning all participants receive the same treatment without comparison groups. During the study, participants will be monitored for tumor response and safety. Key measures include the objective response rate four weeks after treatment, severe adverse events up to 30 days after drug administration or surgery, and major pathologic response after surgery. Participants will also be followed for progression-free survival, overall survival, disease control, and remission duration for up to five years. The study will involve imaging, lab tests, and clinical evaluations throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma
- Gene testing confirmed EGFR mutation
- PET-CT confirmed no metastasis
- ECOG physical status score 0-1
- Age 18 years or older
- At least one measurable lesion
- Good function of major organs including liver, kidney, and blood system with specified lab values
- Fertile female patients must use effective contraception for more than 120 days after treatment and have a negative pregnancy test within 7 days before enrollment
- Unsterilized male patients must use effective contraception for at least 120 days after treatment
- Signed informed consent
You will not qualify if you...
- Other malignant tumors within 5 years before the trial
- Unstable systemic diseases including active infections, uncontrolled hypertension, unstable angina, severe heart failure, severe arrhythmias, liver, kidney, or metabolic diseases
- Active or suspected autoimmune diseases requiring systemic treatment
- History of active bleeding or embolism within 6 months or risk of gastrointestinal bleeding
- Allergy to experimental drugs
- HIV infection or active hepatitis
- Vaccination within 4 weeks before trial start
- Major operations or severe injuries within the previous 2 months
- Clinically uncontrolled pleural effusion or ascites requiring drainage within 2 weeks before admission
- Pregnant or lactating women
- Neurological diseases or mental disorders
- Participation in another therapeutic clinical study concurrently
- Any other condition that researchers consider inappropriate for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 9 weeks
Participants receive Osimertinib as neoadjuvant therapy for their resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma.
Weekly visits for up to 9 weeks
Duration - Up to 30 days after surgery
Participants undergo surgery to remove the lung squamous cell carcinoma after neoadjuvant treatment with Osimertinib.
Approximately 1 surgery visit and post-operative care visits
Duration - Up to 5 years
Participants are monitored for safety and disease outcomes including response rate and survival after treatment and surgery.
Visits at 4 weeks post-treatment, and periodic visits over 2 to 5 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shuben Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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