Non small cell lung cancer
Conditions
Interventions
SAF-189s group:SAF-189s, 160 mg orally once a day, either empty or with food.
Chemotherapy group:Cisplatin 75 mg/m2 on Day 1 + Pemetrexed 500 mg/m2 on Day 1, every 3 weeks for a total of 4 cycles.
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject has fully understood the study and voluntarily signed the informed consent form. 2. Age >= 18, either sex is acceptable. 3. According to UICC/AJCC 8th edition, histologically confirmed completely resected Stage II to IIIB (T3N2M0 only) non-small cell lung cancer (NSCLC) with negative margins, performed 4–12 weeks prior to randomization. (1) Acceptable surgical procedures include any one of the following: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy. (2) Segmentectomy or wedge resection is not permitted. (3) N3 disease is not allowed. 4. If mediastinoscopy was not performed preoperatively, at least systematic mediastinal lymph node sampling is required. (1) Systematic lymph node sampling refers to resection of at least one representative lymph node from designated nodal groups. (2) Complete mediastinal lymph node dissection (MLND) is preferred; MLND requires removal of all lymph nodes within the same nodal group. (3) For subjects undergoing right thoracotomy, sampling or MLND must be performed in nodes of group 4 and group 7; for those undergoing left thoracotomy, sampling or MLND must be performed in nodes of group 5 and/or group 6 and group 7. (4) Exceptions apply: 1) If the subject has documented single-station N2 disease (according to UICC/AJCC 8th edition staging system), sampling of all nodal groups is not required. 2) If preoperative imaging staging (contrast CT and PET scans) shows no evidence of mediastinal disease, the subject may still be considered eligible even if N2 lymph node sampling was not performed as per the surgeon’s discretion. 5. ALK/ROS1-positive NSCLC: (1) Enrollment is permissible based on local laboratory reports showing ALK positivity via Ventana ALK (D5F3) IHC or FISH testing, or via an NMPA-approved assay, or ROS1 positivity reported by a CAP- or CLIA-certified laboratory. If no such compliant local laboratory report is available, central laboratory confirmation of ALK or ROS1 positivity is required for enrollment; all subjects must provide tumor tissue sections or fresh tumor tissue for central laboratory review. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. 7. Adequate organ and bone marrow function (no blood products, growth factors, leukocyte-enhancing agents, platelet-enhancing agents, or anemia-correcting medications permitted within 14 days prior to first dose): (1) Absolute neutrophil count >= 1.5 × 10^9/L (without G-CSF treatment within 7 days). (2) Hemoglobin >= 90 g/L. (3) Platelet count >= 100 × 10^9/L. (4) Serum total bilirubin = 60 mL/min, calculated using the Cockcroft-Gault formula. (7) QTcF corrected by Fridericia’s formula = 50%. 8. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and agree to use a medically accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) from the first dose of study drug until 90 days after the last dose; male subjects with partners of childbearing potential must have undergone sterilization or agree to use effective contr
Exclusion criteria
Exclusion criteria: 1. Patients who have received post-operative radiation therapy (PORT), or those with Stage IIIB N2 disease whom the investigator assesses should receive PORT. Neoadjuvant radiotherapy is permitted if completed at least 4 weeks prior to initiation of study treatment. 2. Prior receipt of systemic anti-tumor therapy. Patients are eligible if they completed curative-intent anti-tumor treatment for an early-stage malignancy more than 5 years before enrollment (i.e., the last dose of curative-intent anti-tumor therapy was administered more than 5 years ago). 3. History of prior treatment with any ALK inhibitor or ROS1 inhibitor. 4. History of hypersensitivity to any of the study drugs that may be randomly assigned (succinate repotrectinib or planned chemotherapy agents), their formulations, or any excipients (mannitol, microcrystalline cellulose, and magnesium stearate) or prophylactic agents. 5. Any unresolved toxicity from prior surgery or neoadjuvant radiotherapy with a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) grade >=2 (alopecia and hyperpigmentation are permitted). 6. Patients with uncontrolled or unstable diabetes, or those receiving insulin therapy (patients on a stable oral hypoglycemic regimen with fasting blood glucose =3, clinically significant arrhythmias (e.g., complete left bundle branch block, second-degree atrioventricular block), known concomitant clinically significant coronary artery disease, cardiomyopathy, severe valvular disease, or uncontrolled hypertension. 13. Impaired hepatic excretory or synthetic function, or other signs of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or esophageal variceal bleeding. 14. Clinically significant active bacterial, fungal, or viral infections, including active hepatitis B (HBsAg-positive with detectable HBV-DNA >=2000 IU/mL or meeting the center’s criteria for active hepatitis B infection) or hepatitis C (HCV-Ab positive); HIV-positive results, or refusal to undergo HIV testing; active infections requiring systemic therapy (including active tubercu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;CNS-DFS (Central Nervous System Disease-Free Survival);Time to subsequent tumor treatment;Safety; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai Oriental Hospital
Outcome results
None listed