EGFR-mutated stage IIIB-IV non-squamous NSCLC complicated by COPD
Conditions
Interventions
Aumolertinib Mesylate First-Line Treatment Group:Aumolertinib Mesylate
Sponsors
Tianjin Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Has a full understanding of the study and voluntarily signs the Informed Consent Form (ICF); 2. Aged 18 to 75 years old, regardless of gender; 3. Histologically and/or cytologically confirmed advanced or recurrent stage IIIB-IV non-squamous NSCLC patients with EGFR mutations (per the 8th edition of the AJCC staging system); 4. Has at least one measurable lesion (per RECIST 1.1); 1.Note: Lesions previously treated with radiotherapy shall not be regarded as target lesions unless there is clear progression of the irradiated lesions. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6. Expected survival of >= 3 months; 7. Adequate organ function: (1). Hematological tests (no blood transfusion, G-CSF administration, or corrective drugs used within 14 days before screening): - Hemoglobin (HB) >= 90 g/L; 2.- Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; 3.- Platelet count (PLT) >= 100 × 10^9/L; 4.- White blood cell count (WBC) >= 4.0 × 10^9/L or the lower limit of normal (LLN) at the study center, and = 30 g/L; 9.- Creatinine (Cr) = 60 mL/min (for cisplatin) or CrCL >= 50 mL/min (for carboplatin) (calculated by the Cockcroft-Gault formula); 10.- Activated partial thromboplastin time (APTT) <= 1.5 × ULN, and international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN (for subjects not receiving anticoagulant therapy); 8. Adverse events resulting from any prior treatment, surgery, or radiotherapy must have resolved to grade 0 or 1 (per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0), except for alopecia of any grade; 9. Willing and able to comply with the study’s visit schedule, treatment plan, laboratory tests, and other study procedures; 10. Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study drug. Women of childbearing potential and male subjects whose partners are of childbearing potential must agree to use highly effective contraceptive methods during the study and for 180 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Target Disease 1). Exclusion of subjects with tumor histologically or cytologically confirmed to have small cell lung cancer components, or squamous cell carcinoma components exceeding 10%; 2). Concomitant with other driver gene mutations with known drug treatments, including but not limited to: ALK gene rearrangement, ROS1 mutation, BRAF600E mutation, NTRK fusion mutation, MET exon 14 skipping mutation, RET fusion mutation, KRAS G12C/HER2 mutation; 3). Prior receipt of systemic chemotherapy for advanced NSCLC; 4). Exclusion of subjects without measurable lesions; 5). Exclusion of subjects with carcinomatous meningitis, spinal cord compression, etc. No definitive surgery and/or radiotherapy has been performed for spinal cord compression, or for previously diagnosed and treated spinal cord compression, there is no evidence that the disease has been clinically stable for >= 2 weeks before randomization; 6). Patients who have received anti-angiogenic drug therapy; 7). Patients who received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks before the first dose. 2. Medical History and Comorbidities 1). Exclusion of subjects with any active, known or suspected autoimmune disease. History of autoimmune diseases includes but is not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis; 1).- Patients with autoimmune-related hypothyroidism receiving a stable dose of thyroid hormone replacement therapy are eligible for the study. - Patients with vitiligo or asthma that completely resolved in childhood and required no intervention in adulthood may be included. 2). Exclusion of subjects who received anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first dose; 3). Exclusion of subjects who are participating in other clinical studies or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical study (last dose); 4). Exclusion of subjects expected to require any other form of anti-tumor treatment during the study (including maintenance therapy with other NSCLC drugs, radiotherapy and/or surgical resection); 5). Subjects who underwent major surgery within 4 weeks before enrollment or have not fully recovered from previous surgery; 6). Subjects who received non-thoracic radiotherapy > 30 Gy within 4 weeks before the first dose, or thoracic radiotherapy before the first dose; 7). Exclusion of subjects with highly suspected interstitial pneumonia; or subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity; or other moderate to severe pulmonary diseases that seriously affect lung function; 8). Exclusion of subjects with other active malignant tumors requiring concurrent treatment; 9). Exclusion of subjects with other malignant tumors except non-small cell lung cancer within 5 years before the first dose. Malignant tumors with negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) and expected curati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) related to the study drug,Abnormal laboratory test values,Serious Adverse Events (SAEs);Disease Control Rate (DCR),Overall Survival (OS),Duration of Response (DoR); | — |
Countries
China
Contacts
Public ContactMaHui
Tianjin Chest Hospital
Outcome results
None listed