Actively Recruiting
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2024-05-09
51
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.
CONDITIONS
Official 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 resectable stage II-IIIB lung squamous cell carcinoma
- Genetic testing confirmed EGFR mutation
- PET-CT showed no metastasis
- ECOG performance status score of 0 or 1
- Age 18 years or older
- At least one measurable tumor lesion
- Good function of major organs including liver, kidney, and blood system with specified lab values
- Fertile female patients must use effective contraception for at least 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 the last 5 years
- Unstable systemic diseases such as active infections, uncontrolled hypertension, severe heart conditions, liver, kidney, or metabolic diseases
- Active or suspected autoimmune diseases requiring systemic treatment
- History of active bleeding or embolism within 6 months or high risk of gastrointestinal bleeding
- Allergy to the study drug
- HIV infection or active hepatitis
- Vaccination within 4 weeks before the trial
- Major surgery or severe injuries within 2 months prior to the trial
- 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 deemed inappropriate for enrollment by the researchers
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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