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Trial Title:
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
NCT ID:
NCT06383728
Condition:
Lung Cancer
Carcinoma, Squamous Cell
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Osimertinib
Conditions: Keywords:
neoadjuvant targeted therapy
EGFR-mutated lung squamous cell carcinoma
surgery
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive
osimertinib (80mg/d, ≥9 weeks)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will
receive Osimertinib ( 80mg/d, ≥9 weeks).
Arm group label:
Osimertinib
Other name:
Tagrisso
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuben Li, Doctor
Email:
13500030280@163.com
Start date:
April 1, 2024
Completion date:
April 30, 2029
Lead sponsor:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
The First Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06383728
