Resectable EGFR-Mutated Non-Small Cell Lung Cancer
Conditions
Interventions
Treatment Group:Limertinib Followed by Sintilimab Combined with Cisplatin/Carboplatin and Pemetrexed
Control Group:Limertinib Followed by Limertinib Combined with Cisplatin/Carboplatin and Pemetrexed
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form; 2. Age: 18–75 years. 3. Cytologically/histologically confirmed (via percutaneous lung puncture, bronchoscopy, mediastinoscopy, etc.), previously untreated stage II–IIIB (IASLC 8th Edition Thoracic Tumor Classification) lung adenocarcinoma. 4. Tumor tissue or blood samples confirmed as EGFR-sensitive or rare mutation-positive by laboratory testing; 5. Must provide archived tumor tissue or newly resected tumor biopsy samples for PD-L1 IHC testing during screening. 6. Eastern Cooperative Oncology Group (ECOG) performance status =1.5×10^9/L, platelets >=100×10^9/L, hemoglobin >=100 g/L. Hepatic: Total bilirubin =35 g/L. Renal: Serum creatinine =60 mL/min (Cockcroft-Gault formula); urine protein <2+ or 24-hour urine protein <1 g. Cockcroft-Gault formula: Female: CrCl = [(140 – age) × weight (kg) × 0.85] / [72 × serum creatinine (mg/dL)]. Male: CrCl = [(140 – age) × weight (kg)] / [72 × serum creatinine (mg/dL)]. Coagulation: INR <=1.5×ULN; PT/APTT <=1.5×ULN. 10. For women of childbearing potential: Negative urine/serum pregnancy test within 7 days prior to first dose. Confirmatory blood test required if urine test is positive.
Exclusion criteria
Exclusion criteria: 1. Patients with stage I or IV NSCLC who have previously received systemic anti-tumor therapies (e.g., ICIs, targeted therapy, chemotherapy). 2. Active known or suspected autoimmune diseases (exceptions: type I diabetes, hypothyroidism requiring hormone replacement only, non-progressive skin conditions like vitiligo/psoriasis/alopecia). 3. Active hepatitis B (HBsAg-positive) or hepatitis C (HCV RNA-positive). Patients with resolved HBV infection (HBsAg-negative, HBcAb-positive) must provide HBV DNA-negative results. HCV antibody-positive patients require negative HCV RNA PCR. 4. HIV-positive or AIDS history. 5. Arterial thrombosis within 6 months, or deep vein thrombosis/pulmonary embolism within 3 months. 6. Uncontrolled angina, arrhythmias, or congestive heart failure. 7. Active malignancies within 5 years (except cured cervical/cutaneous carcinoma in situ, superficial bladder/prostate/breast cancer). 8. Contraindications to local therapies (surgery, radiotherapy, or intervention) per investigator judgment. 9. Hypersensitivity to sintilimab, liotinib, chemotherapy agents, or excipients. 10. Unwillingness to sign informed consent or comply with follow-up. 11. Any condition compromising trial integrity or patient safety, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Events Free Survival;overall survival;major pathological response(MPR) rate;objective response rate(ORR); | — |
Countries
China
Contacts
Public ContactZhong Wenzhao
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed