Post-complete resection stage IB-IIIB ROS1-mutant non-small cell lung cancer
Conditions
Interventions
Treatment group:TQ-B3101
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is able to understand the informed consent, voluntarily participate and sign the informed consent; 2. Subject age>=18 years old, gender is not limited; 3. Subject has recovered from surgery (or chemotherapy) with a performance status (ECOG) score of 0 or 1 in the Eastern Oncology Cooperative Group; 4. High-risk stage IB confirmed by histopathology after complete resection (at least one of the following high-risk factors for recurrence must be included: such as visceral pleural invasion [VPI], lymphatic vascular invasion [LVI], airspace dissemination [STAS], poorly differentiated pathological type or adenocarcinoma subtype, or other clinically considered high-risk factors) - stage IIIB (except N3) NSCLC (AJCC 8th edition); 5. Subjects must have completely resected NSCLC (no residual tumor and all surgical margins are negative); Resection modalities include: lobectomy, sleeve lobectomy, double lobectomy, segmentectomy (to be assessed as complete resection by the investigator) or pneumonectomy; and systemic mediastinal lymph node dissection or lobe-specific mediastinal lymph node dissection; 6. Subjects must have completely resected NSCLC (no residual tumor and all surgical margins are negative); 7. Tumor tissue samples are confirmed to be ROS1 mutations (detection methods include PCR, NGS, FISH, etc.); 8. Head imaging examination is required before surgery or enrollment (MRI with contrast to the brain is preferred); 9. The investigator or attending physician will discuss and decide whether to administer postoperative adjuvant chemotherapy first, and complete enrollment within 12 weeks or 28 weeks after surgery according to whether adjuvant chemotherapy is administered, and the regimen is based on platinum-containing drugs and does not exceed 4 cycles. 10. Organ function meeting the following criteria within 10 days prior to the first dose: Bone marrow function: Hemoglobin > = 90 g/L; Absolute neutrophil count >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Renal function: Serum creatinine =60 mL/min (calculated according to the Cockcroft-Gault formula) Liver function: Aminotransferases (ALT and AST) < = 3 x ULN; 11. Females of childbearing potential need to take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping study treatment, and have a negative pregnancy test before starting dosing; 12. Male patients should use barrier contraception (i.e., condoms) from screening until 3 months after discontinuation of study treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone wedge resection only. 2. Received neoadjuvant therapy before surgery; 3. Received other targeted therapy or immunotherapy after surgery; 4. Concomitant other malignant tumors within 5 years before the first dose and need to actively continue anti-tumor therapy, except for cured tumors evaluated by the investigator; 5. Refractory nausea, vomiting or chronic gastrointestinal disease, unable to swallow the study drug or have undergone extensive bowel resection, which may affect the adequate absorption of the drug; 6. Any serious or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, or active hepatitis, HIV, etc., except for those who, in the opinion of the investigator, do not affect the safety of the subject and their compliance with the trial protocol; 7. History of previous allogeneic bone marrow or organ transplantation; 8. Symptomatic sinus bradycardia; 9. Has a history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease; 10. Pregnant and/or lactating females; 11. Patients who may have poor compliance with the procedures and requirements of the study as judged by the investigator, such as patients with mental illnesses, etc.; 12. Patients with any condition that jeopardizes patient safety or interferes with study evaluation, as judged by the investigator; 13. History of hypersensitivity to any active or inactive ingredient of the drug or to drugs similar to the chemical structure of the drug or of the same class; 14. Any serious or uncontrolled ocular lesions, which may increase the safety risk of the patient in the judgment of the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year disease free survival rate;3-year overall survival rate;5-year overall survival rate;3-year disease free survival rate; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed