Advanced NSCLC
Conditions
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.
Interventions
camrelizumab for intravenous injection; famitinib malate capsules for oral administration
DRUGfamitinib
famitinib malate capsules for oral administration
DRUGdocetaxel
docetaxel for intravenous injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Camrelizumab Combined with Famitinib Malate Versus Docetaxel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer. 2. Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment. 3. Have measurable disease based on RECIST v1.1. 4. ECOG PS score: 0-1. 5. Expected survival ≥ 3 months. 6. 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. 7. Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.
Exclusion criteria
1. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites. 2. Have known history of prior malignancy in the past 3 years. 3. Have active pulmonary tuberculosis. 4. Have clinical symptoms of the heart or heart diseases that are not well controlled. 5. Have hypertension which cannot be well controlled by antihypertensives 6. 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. 7. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy. 8. 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. 9. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism. 10. 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. 11. Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib. 12. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed