Advanced Non-Small Cell Lung Cancer with EGFR positive mutation
Conditions
Interventions
ABOR2013 mono therapy Group:ABOR2013 injection
Combination Group:ABOR2013 + Sintilimab Injection
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above; 2. Patients who have signed Informed Consent Form (ICF) and are able to perform follow-up visits and the required procedures; 3. Diagnosed non-small cell lung cancer with at least one activating EGFR positive-mutation (L858R/19del[E746_A750del]/T790M) and Not suitable for standard treatment; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 12 weeks; 6. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; 7. Agreed to provide tumor tissue samples used for biopsy; 8. The organ function level must meet the following requirements and meet the following standards: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 90 x 10^9/L, hemoglobin >= 90 g/L; and the patient has not received the following treatments in the week before screening: transfusions of blood or platelets, use of drugs that promote leukocyte elevation (such as colony-stimulating factors) and erythropoietin (EPO); (2) Liver function: total bilirubin (TBIL) = 50 mL/min (according to the Cockcroft and Gault formula); urine protein 50%; (5) Coagulation function: international normalized ratio (INR) <= 1.5 x ULN, and activated partial thromboplastin time (APTT) <= 1.5 x ULN; 9. Patients with reproductive potential must agree to use effective contraceptive methods from signing ICF to 120 days after the end of treatment; female patients with reproductive potential must have a negative urine or serum pregnancy test before start of the trial.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors in the past 5 years, except cured skin basal cell carcinoma, superficial bladder cancer, breast carcinoma in situ and cervical carcinoma in situ; 2. Central nervous system tumors or metastases with clinical symptoms, and patients with brain metastases who have previously received treatment, if clinically stable and have not used systemic steroids for at least 8 weeks before enrollment in the study; 3. A history of severe heart disease, such as symptomatic congestive heart failure (CHF) >= Level 2 (NCI CTCAE 5.0), heart failure >= Level 2 at the New York Heart Association (NYHA), history of transmural myocardial infarction, unstable angina, and poorly controlled arrhythmia; 4. Hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) and type 2 diabetes (fasting blood glucose >= 8.9 mmol/L) that cannot be controlled by two antihypertensive drugs; 5. Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis that requires systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases, and Hashimoto's thyroiditis; type 1 diabetes, hypothyroidism that can be controlled only by alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo and psoriasis) can be included in the trial; 6. Has received any systemic anti-tumor therapy, including experimental medication, within 28 days or 5 half-lives (whichever is shorter) prior to the first administration; 7. Received radiation therapy within 14 days before the first administration; 8. Inoculate with live or attenuated vaccines within 30 days before the first administration; 9. Immunosuppressants have been used within 14 days prior to or during the first administration; 10. Major surgery performed within 28 days prior to the first administration or non-study related minor surgery performed within 7 days prior to the first administration; 11. Prior to the first administration, there was a history of rapid onset severe allergic reactions; 12. Long term use of immunosuppressants or other immunomodulatory drugs within 6 months (continuous use >= 14 days) (For example, corticosteroids such as prednisone or similar drugs), but local medication (such as ointments, eye drops, inhalants, or nasal sprays) is allowed, and local medication should not exceed the recommended dosage in the instruction manual or have any signs of systemic exposure; Or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 13. If a thrombotic disease occurs within 6 months before screening or full dose anticoagulant therapy is used; systemic anticoagulant drugs need to be used during intertumoral injection or biopsy; 14. The acute toxic effects of previous anticancer chemotherapy or immunotherapy (CTCAE >= level 2) have not been stabilized, or significant post treatment toxicity has been observed. (Note: The chronic toxic effects of previous anticancer treatments, such as chemotherapy induced < CTCAE grade 2 neuropathy, fatigue, alopecia, or anorexia, which are not expected to further recover, will not hinder participation in this study); 15. Subjects with irreversible toxicity can be selected at the discretion of the investigator; 16. The presence of clinically significant pulmonary fibrosis or interstitial pneumonia has been determined by investigators; active pulmonary infection before administration requires anti infection treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile;dose-limiting toxicity, DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;Duration of remission, DOR;progression-free survival, PFS;Overall survival, OS;pharmacokinetics, PK; | — |
Countries
China
Contacts
Public ContactJianxing He
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed