Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Non-small Cell Lung Cancer
EGFR Activating Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3)...
Detailed Description
35 eligible patients will be enrolled and 3 cycles of Sintilimab 200mg + doublet platinum-based chemotherapy will be administered. Dynamic blood samples before, during or after neoadjuvant treatment w...
Eligibility Criteria
Inclusion
- Age :18 Years to 75 Years;
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
- Pathologically confirmed diagnosis with Stage II-IIIB(N2) NSCLC which harbored sensitive and rare EGFR alteration. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed;
- At least one measurable target lesion according to the RECIST 1.1 standard;
- The main organ function meets the following criteria: 1) blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.
Exclusion
- Stage I and stage IV NSCLC;
- Large panel NGS indicated ALK fusion or any other driver mutations;
- Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
- Patients who have previously used any other anti-tumor drugs or radiotherapy;
- A history of active bleeding within the 6 months before enrollment, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
- Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
- Patients with low compliance or willingness to take the drugs and surveillance.
Key Trial Info
Start Date :
June 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05244213
Start Date
June 4 2022
End Date
December 1 2025
Last Update
July 8 2024
Active Locations (1)
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1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080