Lung cancer
Conditions
Interventions
Treatment group (Treatment with Ivonescimab):None
Sponsors
Higher Education Mega Center Hospital of Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent; 2. Age =18 years old at the time of enrollment, both male and female; 3. Histologically or cytologically proven locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC that cannot be completely resected by surgery and cannot be treated with radical synchronous/sequential chemoracial chemotherapy (according to the International Union against Cancer and the American Joint Committee on Cancer 8th Edition TNM staging of lung cancer); 4. Positive EGFR activating mutations were confirmed by tumor histology, cytology or hematology before enrollment, including exon 18 point mutation (G719X), exon 19 deletion (19Del), exon 20 point mutation (S768I, T790M), exon 21 point mutation (L858R, L861Q); 5. Previous treatment with EGFR-TKI has failed, meeting any of the following requirements: 1) Progression after 1st or 2nd generation EGFR-TKI treatment (e.g. Gefitinib, erlotinib, ecotinib, afatinib, darcotinib, etc.), and T790M mutation has been reported to be negative after 1st or 2nd generation EGFR-TKI progression; 2) Progression after treatment with third-generation EGFR-TKI (e.g., ocitinib, ametinib, and vometinib). 6. Determine good organ function through the following requirements 7. Use effective birth control
Exclusion criteria
Exclusion criteria: 1. Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component of squamous cell carcinoma; 2. There have been reports of other driver gene mutations with known drug treatments; 3. Received EGFR-TKI treatment within 2 weeks before the first dose; Palliative local treatment was performed for non-target lesions within 2 weeks before the first administration; Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week before the first administration; 4. Imaging during the screening period showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the researchers determined that entering the study would cause bleeding risk; 5. Patients with chest radiation >30 Gy within 6 months before the first dose, patients with non-chest radiation >30 Gy within 4 weeks before the first dose, and patients with palliative radiation =30 Gy within 2 weeks before the first dose, Patients who did not recover from the toxicity and/or complications of these interventions to NCI-CTC AE = Class 1 (except hair loss and fatigue). To permit palliative radiotherapy for symptom control, it must be completed at least 2 weeks before the first dose and no additional radiotherapy for the same lesion is planned; The presence of any past or current disease, treatment, or laboratory abnormalities that may confuse the study results, affect the patient's full participation in the study, or that participation in the study may not be in the patient's best interest;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;During of response;Time to response;Safety; | — |
Countries
China
Contacts
Public ContactLi liuning
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed