Status:
UNKNOWN
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failu...
Eligibility Criteria
Inclusion
- Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
- 18 to 75 years old, male or female.
- Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
- ECOG Performance Status of 0 or 1.
- Adequate hematological, hepatic and renal function.
- Female subjects of child-bearing potential must have a negative serum HCG test before treatment.
Exclusion
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Untreated central nervous system metastases.
- Cancerous meningitis (meningeal metastasis).
- Uncontrolled pleural effusion, pericardial effusion or ascites.
- Tumor infiltration into the great vessels on imaging;
- Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
- Uncontrolled tumor-related pain.
- Malignancies other than SCLC within 5 years.
- Systemic antitumor therapy was received 4 weeks prior to trial treatment.
- History of autoimmune diseases.
- Significant cardiovascular disease.
- Inadequately controlled hypertension.
- Known history of testing positive test for HIV or known AIDS.
- Patients with active hepatitis B or hepatitis C
- Severe infections within 4 weeks prior to trial treatment.
- Active tuberculosis.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04884009
Start Date
May 31 2021
End Date
December 31 2022
Last Update
May 12 2021
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