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
1 other identifier
interventional
106
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lung-cancer
Started May 2021
Shorter than P25 for phase_2 lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedStudy Start
First participant enrolled
May 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 12, 2021
May 1, 2021
1.6 years
May 7, 2021
May 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) based on RECIST 1.1 criteria
up to approximately 1 year.
Secondary Outcomes (5)
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.
Study Arms (2)
SHR-1701+ Famitinib
EXPERIMENTALSHR-1701
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2021
First Posted
May 12, 2021
Study Start
May 31, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 12, 2021
Record last verified: 2021-05