Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Launched by THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of lung cancer called EGFR-mutated lung squamous cell carcinoma. The goal is to see if a targeted therapy, known as osimertinib, can be given before surgery to shrink tumors and improve treatment outcomes. This approach has shown promise in other studies involving different lung cancer types, but there hasn't been much research focused on this specific group of patients, so this trial aims to fill that gap.

To be eligible for the trial, patients must be at least 18 years old and have a confirmed diagnosis of resectable stage II-IIIB lung squamous cell carcinoma with an EGFR mutation. They should have no signs of cancer spreading to other parts of the body and must be in good general health. Participants will receive the targeted therapy for a set period before their surgery, and they will be closely monitored for their response to the treatment and any side effects. It's important for potential participants to discuss this opportunity with their healthcare team to determine if they meet the criteria and if this trial is the right choice for them.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;
• • 2. Gene text confirmed EGFR mutation;
• • 3. PET-CT confirmed no metastasis;
• • 4. ECOG physical status score 0-1;
• • 5. Age ≥ 18 years;
• • 6. Have one measurable lesion at least;
• • 7. Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be \< 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
• • 8. Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after treatment, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after treatment;
• • 9. Sign informed consent.
• Exclusion Criteria:
• • 1. Patients with other malignant tumors in the five years before the start of this trial.
• • 2. Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure \[higher than II (New York College of Cardiology)\], severe arrhythmias, liver, kidney or metabolic diseases;
• • 3. Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
• • 4. A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
• • 5. Allergic to experimental drugs;
• • 6. Complicated with HIV infection or active hepatitis.
• • 7. Vaccination within 4 weeks before the start of this trial;
• • 8. Those who had undergone other major operations or severe injuries within the previous 2 months;
• • 9. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
• • 10. Pregnant or lactating women;
• • 11. Those with neurological diseases or mental disorders;
• • 12. Participated in another therapeutic clinical study at the same time;
• • 13. Other researchers did not consider it appropriate to enroll in the group.