Clinical trial NCT06383728: Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Carcinoma, Squamous Cell
Keywords: neoadjuvant targeted therapy
EGFR-mutated lung squamous cell carcinoma
surgery
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This trial aims to investigated the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma.

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.

Primary outcomes:
measure: Objective Response Rate, ORR
timeFrame: analysis is completed 4 weeks after neoadjuvant treatment
measure: Safety: frequency of severe adverse events
timeFrame: from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
Secondary outcomes:
measure: Major pathologic response, MPR
timeFrame: analysis is completed 4 weeks after surgery
measure: R0 rate
timeFrame: analysis is completed 4 weeks after surgery
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Disease control rate (DCR)
timeFrame: 2 years
measure: Duration of remission (DOR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: shuben Li, Doctor
role: STUDY_DIRECTOR
References: