Non small cell lung cancer (NSCLC)
Conditions
Interventions
ctDNA-positive patients:Nil
ctDNA-negative patients:Nil
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, aged >=18 years. 2. Patients with primary NSCLC confirmed by histology, mainly non-squamous carcinoma patients. 3. Chest CT, abdominal B-ultrasound and brain MRI must be performed before surgery to exclude metastasis or second primary tumor. 4. Postoperative patients must be diagnosed as stage IB, II or IIIA according to pathology. 5. Tissue sequencing confirmed the presence of one of 2 common EGFR mutations (19DEL, L858R), alone or in combination with other EGFR mutations including T790M. 6. The patient underwent R0 resection, and the surgical margins must be negative. And at the end of the surgery, all serious disease had been removed. 7. When adjuvant targeted therapy, the patient has fully recovered from surgery. 8. The World Health Organization performance status PS is 0-1. 9. Female patients should use adequate contraception, should not breastfeed, and have a negative pregnancy test prior to the first dose, or evidence of non-reproductive potential in the female.
Exclusion criteria
Exclusion criteria: 1. Preoperative, or postoperative, or planned radiation therapy. 2. Preoperative (neoadjuvant) chemotherapy containing platinum or other chemotherapy. 3. Prior treatment for any cancer. 4. Have received neoadjuvant or adjuvant EGFR-TKI therapy. 5. Major surgery (including primary tumor surgery) is performed within 4 weeks of initial dosing. 6. Currently receiving cytochrome P450(CYP)3A4 strong inducer medication or herbal supplement. 7. For investigational drugs that have been enrolled in other clinical studies (except retrospective observational studies without intervention) within 4 weeks prior to initial dosing or are still in other clinical studies within 5 half-lives, whichever is the older. 8. Undergo a segmentectomy or wedge resection. 9. History of other malignancies, with the exception of adequately treated non-melanoma skin cancer, radical treatment for carcinoma in situ, or other solid tumors that have been radical treatment and have shown no evidence of disease for 5 years after the end of treatment. 10. At entry into the study, any unresolved toxicity from prior treatment was greater than CTCAE Grade 1, except for hair loss and grade 2, neuropathy associated with prior platinum-based treatment. 11. Any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding diathesis; Or active infections, including hepatitis B, hepatitis C and HIV. 12. Any cardiac criteria including mean resting corrected QT interval (QTc) > 470 ms, obtained from 3 electrocardiograms, using QTc values derived from screening clinic electrocardiogram machines. Any clinically significant abnormality in the rhythm, conduction, or morphology of the resting ECG. Any factors that increase the risk of prolonged QTc intervals or arrhythmia events, or the risk of sudden unexplained death in a first-degree relative under 40 years of age, or any concomitant medications known to prolong QT intervals. 13. Previous history of ILD, drug-induced ILD, radiation pneumonia requiring steroid treatment, or any evidence of clinically active ILD. 14. Insufficient bone marrow reserve or organ function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative ctDNA-pos and ctDNA-neg;ctDNA-pos and ctDNA-neg after targeted adjuvant therapy; | — |
Countries
China
Contacts
Public ContactYang Shengli
Outcome results
None listed