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

Lung Cancer Clinical Trial

Official title:

An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04884009
• Other study ID #: SHR-1701-II-209
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Wei Shi
• Phone: 021-68868570
• Email: wei.shi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 failure of previous systemic chemotherapy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• SHR-1701; Famitinib
SHR-1701+ Famitinib
• SHR-1701
SHR-1701

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) based on RECIST 1.1 criteria		up to approximately 1 year.
Secondary	Progression free survival (PFS) based on RECIST 1.1 criteria		up to approximately 1 year.
Secondary	Disease control rate (DCR) based on RECIST 1.1 criteria		up to approximately 1 year.
Secondary	Duration of response (DoR)		up to approximately 1 year
Secondary	Overall survival (OS)		up to approximately 1 year
Secondary	AEs+ SAEs determined by NCI-CTCAE V5.0		Baseline until up to 90 days after end of treatment.