Neoadjuvant targeted therapy for lung cancer patients with specific mutations

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

This study is testing if a targeted therapy called osimertinib can safely shrink tumors in lung cancer patients with specific mutations before surgery to help improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: osimertinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06383728 on ClinicalTrials.gov

What this trial studies

This trial investigates the safety and feasibility of using osimertinib, a targeted therapy, as a neoadjuvant treatment for patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma. The study aims to determine if this approach can effectively reduce tumor size and improve surgical outcomes. Previous trials have shown benefits of neoadjuvant therapy in other types of lung cancer, but this specific population has been underrepresented in clinical research. The trial will enroll patients who meet specific eligibility criteria, including confirmed EGFR mutations and no metastasis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resectable stage II-IIIB lung squamous cell carcinoma and confirmed EGFR mutations.

Not a fit: Patients with non-resectable lung cancer or those without EGFR mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved surgical outcomes and survival rates for patients with EGFR-mutated lung squamous cell carcinoma.

How similar studies have performed: Previous studies have shown success with neoadjuvant targeted therapies in other lung cancer types, but this specific approach in EGFR-mutated lung squamous cell carcinoma is less tested.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Shuben Li, Doctor

Conditions: Lung Cancer, Carcinoma, Squamous Cell, neoadjuvant targeted therapy, EGFR-mutated lung squamous cell carcinoma, surgery