A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC
Study Details
Study Description
Brief Summary
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm A camrelizumab + famitinib |
Drug: camrelizumab + famitinib
camrelizumab for intravenous injection; famitinib malate capsules for oral administration
|
| Experimental: Treatment Arm C famitinib |
Drug: famitinib
famitinib malate capsules for oral administration
|
| Active Comparator: Treatment Arm B docetaxel |
Drug: docetaxel
docetaxel for intravenous injection
|
Outcome Measures
Primary Outcome Measures
- OS [up to 4 years]
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.
Secondary Outcome Measures
- PFS [up to 4 years]
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.
- ORR [up to 4 years]
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points.
- DoR [up to 4 years]
Duration of Response, determined using RECIST v1.1 criteria.
- DCR [up to 4 years]
Disease Control Rate, determined using RECIST v1.1 criteria.
- TTF [up to 4 years]
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
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Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
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Have measurable disease based on RECIST v1.1.
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ECOG PS score: 0-1.
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Expected survival ≥ 3 months.
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Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
-
Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.
Exclusion Criteria:
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Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
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Have known history of prior malignancy in the past 3 years.
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Have active pulmonary tuberculosis.
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Have clinical symptoms of the heart or heart diseases that are not well controlled.
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Have hypertension which cannot be well controlled by antihypertensives
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Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
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Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
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Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
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Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
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Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
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Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
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Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Subei People's Hospital of Jiangsu Province | Yangzhou | Jiangsu | China | 225001 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1210-III-332