Clareo Health | A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC
A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC
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.
7. Measurable lesions per RECIST v1.1.
8. Surgically evaluated as eligible for local surgical resection (adequate pulmonary/organ function).Surgically evaluated as eligible for local surgical resection (adequate pulmonary/organ function).
9. Adequate organ and bone marrow function (within 7 days prior to enrollment; no corrective therapies within 14 days prior to testing): • Hematology: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥100 g/L. • Hepatic: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN; albumin ≥35 g/L. • Renal: Serum creatinine ≤1.5×ULN; CrCl ≥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.
You may not be if
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, limertinib, 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.
