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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04884009

Enrollment

106

Registered

2021-05-12

Start date

2021-05-31

Completion date

2022-12-31

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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 failure of previous systemic chemotherapy

Interventions

DRUGSHR-1701； Famitinib

SHR-1701+ Famitinib

DRUGSHR-1701

SHR-1701

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

SHR-1701 in combination with or without famitinib

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) based on RECIST 1.1 criteria	up to approximately 1 year.

Secondary

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

Contacts

Primary ContactWei Shi

wei.shi@hengrui.com021-68868570

Backup ContactHuan Li

huan.li@hengrui.com17721286513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026