NCT06383728 Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
| NCT ID | NCT06383728 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2024-04-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
shuben Li, Doctor
STUDY DIRECTOR
The First Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT06383728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06383728 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06383728 currently recruiting?
Yes, NCT06383728 is actively recruiting participants. Contact the research team at 13500030280@163.com for enrollment information.
Where is the NCT06383728 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06383728 clinical trial?
NCT06383728 is sponsored by The First Affiliated Hospital of Guangzhou Medical University. The principal investigator is shuben Li, Doctor at The First Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 51 participants.
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