Clareo Health | A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy
A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy
1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.
2. Aged ≥ 18 years, male or female.
3. Patients with initial diagnosis of EGFR-mutated NSCLC and histologically or cytologically confirmed transformation to SCLC following treatment with EGFR tyrosine kinase inhibitor.
4. After transformation to SCLC, the patient's prior treatment history must meet one of the following criteria:
* Progression after only receiving platinum-based treatment regimens.
* No prior systemic therapy for SCLC.
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
6. Life expectancy ≥ 12 weeks.
You may not be if
1. Patients with symptomatic brain metastases or carcinoma meningitis. Note:
* Patients with treated brain metastases may participate in this study if the patient has completed radiotherapy or surgery for brain metastases ≥ 4 weeks prior to study entry, and neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment \[i.e., no new findings on brain imaging and no new neurologic deficits from brain metastasis on screening examination, and high doses of corticosteroids (\> 10 mg prednisone daily or equivalent) were not required within 4 weeks prior to enrollment\].
2. Patients who have a history of another primary malignancy (with the exception of patients with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
3. Patients with tumors that had invaded important blood vessels as shown in the screening imaging and that the investigators assessed were highly likely to cause fatal bleeding during the study.
4. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
5. Patients with Gilbert's syndrome disease.
6. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.
7. Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level ≥ 200 IU/mL for hepatitis C or HBV DNA level ≥ 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.
8. Patients who have not sufficient baseline organ function.
9. Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0020 Injection, or who have a predisposition to allergy.
10. Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin \[≤ 100 mg/day\] or low molecular weight heparin is allowed).
11. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before enrollment or scheduled to receive during the study.
12. Pregnant or lactating women.
13. Patients who are assessed disqualified to join clinical studies by investigator due to any causes.
