Lung cancer
Conditions
Interventions
T790M positive patients:Aumolertinib
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced (stage IIIB) or metastatic (stage IV) NON-small cell lung cancer with positive EGFR-resistant mutations who are unable to undergo curative surgery or radiotherapy and whose T790M mutation is confirmed; 2. Be at least 18 years old when signing informed consent; 3. Aumolertinib monotherapy for second-line treatment; 4. Adequate bone marrow and organ function confirmed by baseline total blood count, blood biochemical and urinary biochemical tests; (1) Neutrophil count >= 1.5 x 10^9/L; (2) Platelet count >= 80 x 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Creatinine clearance <= 1.5 times the upper limit of normal value; (5) AST and ALT <= 5 times the upper limit of normal value in patients with liver metastasis and <= 2.5 times the upper limit of normal value in patients without liver metastasis; (6) Total bilirubin <= 1.5 times upper limit of normal value; 5. World Health Organization (WHO) physical status score 0-2; 6. Patients who received Aumolertinib with a clear tumor response assessment (CR or PR); 7. Patients receiving Aumolertinib treatment with remission period of more than 3 months; 8. Patients who volunteered for secondary biopsy or peripheral blood driver gene testing after Aumolertinib treatment progression.
Exclusion criteria
Exclusion criteria: 1. A history of allergy to any active or inactive ingredient of Aumolertinib or to drugs with a similar chemical structure or class to Aumolertinib; 2. Have received or are currently receiving other three generations of EGFR-TKI therapy; 3. Patients who received Aumolertinib in combination with other treatments include but are not limited to the following: chemotherapy drugs, experimental drugs or other anticancer drugs, anti-angiogenic drugs, immune checkpoint inhibitors, etc. Local radiotherapy is not included in this limitation; 4. Patients who cannot effectively provide secondary biopsy or peripheral blood driver gene testing after Aumolertinib treatment progression; 5. Patients who did not obtain a definitive tumor response assessment (CR or PR) after Aumolertinib treatment; 6. Patients with remission period less than 3 months after Aumolertinib treatment; 7. Patients who did not undergo driver gene testing before Aumolertinib treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficiency evaluation; | — |
Countries
China
Contacts
Public ContactFeng Lingxin
The Affiliated Hospital of Qingdao University
Outcome results
None listed