A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer

Treatments: Drug: SHR-1701； Famitinib; Drug: SHR-1701

Study type: Interventional

Funder types: Industry

Identifiers

NCT04884009

SHR-1701-II-209

Details and patient eligibility

About

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 failure of previous systemic chemotherapy

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
2. 18 to 75 years old, male or female.
3. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
4. ECOG Performance Status of 0 or 1.
5. Adequate hematological, hepatic and renal function.
6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion criteria

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Untreated central nervous system metastases.
3. Cancerous meningitis (meningeal metastasis).
4. Uncontrolled pleural effusion, pericardial effusion or ascites.
5. Tumor infiltration into the great vessels on imaging;
6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
7. Uncontrolled tumor-related pain.
8. Malignancies other than SCLC within 5 years.
9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
10. History of autoimmune diseases.
11. Significant cardiovascular disease.
12. Inadequately controlled hypertension.
13. Known history of testing positive test for HIV or known AIDS.
14. Patients with active hepatitis B or hepatitis C
15. Severe infections within 4 weeks prior to trial treatment.
16. Active tuberculosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

SHR-1701+ Famitinib

Experimental group

Treatment:

Drug: SHR-1701； Famitinib

SHR-1701

Experimental group

Treatment:

Drug: SHR-1701