- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04731909
Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer
February 8, 2021 updated by: Dong Wang, Third Military Medical University
Clinical Study of Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer
To evaluates the effectiveness and safety of Toripalimab combined with Anlotinib and chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Toripalimab combined with Anlotinib.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Recruiting
- Daping Hospital, Third Military Medical University
-
Contact:
- Dong Wang, PH.D
- Phone Number: +862368757181
- Email: dongwang64@hotmail.com
-
Principal Investigator:
- Dong Wang, PH.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: 18-75 years old;
- Expected survival period ≥ 3 months;
- Small cell lung cancer confirmed by histology or cytology, extensive stage disease (American Joint Committee on Cancer (7th edition) stage IV SCLC [any T stage, any N stage and Mla/b]), or T3-4 adult patients(≥18 years old) who cannot be included in a tolerable radiotherapy plan due to a wide range of multiple lung nodules or the tumor/nodule size is too large;
- According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter(The long diameter of CT scan of tumor lesions is ≥10 mm, the short diameter of CT scan of lymph node lesions is ≥15 mm, and the scan thickness is not more than 5 mm);
- ECOG PS: 0-2;
- Patients with brain metastases must be asymptomatic or stable on treatment with steroids and anticonvulsants within 1 month before study treatment;
- The patient must be considered suitable for platinum-based chemotherapy as the first-line treatment for SCLC, Chemotherapy must include either cisplatin or carboplatin, combined with etoposide;
- Laboratory test indicators must meet the following requirements: Hematology: white blood cells ≥4.0×10^9/L, neutrophils ≥2.0×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90g/L. Liver function: serum bilirubin is lower than 1.5 times the maximum normal value; for patients without liver metastasis: ALT and AST are lower than 2.5 times the maximum normal value; for patients with liver metastasis: ALT and AST are lower than 5 times the maximum normal value ; Measured or calculated creatinine clearance: According to the Cockcroft-Gault formula (using actual body weight), patients receiving cisplatin treatment>60mL/min, and patients receiving carboplatin treatment>45mL/min;
- Good compliance and follow-up;
- The urine or serum pregnancy test results of premenopausal women were negative.
Exclusion Criteria:
- Participated in another clinical study within the last 4 weeks and received etoposide + platinum (cisplatin or carboplatin) administration;
- There is a medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy;
- Patients who have previously received vascular endostatin (such as bevacizumab, Regorafenib, etc.) ;
- Allow radiation therapy outside the chest (ie, bone metastases) for the purpose of palliative care;
- Etoposide + platinum (cisplatin or carboplatin) received major surgery within 28 days before the first dose (defined by the investigator). Note: For the purpose of palliative care, local surgery on isolated lesions is acceptable;
- Patients with symptomatic brain metastases;
- People with hypertension who cannot be well controlled by a single antihypertensive drug (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
- Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0g;
- Cardiovascular disease history: congestive heart failure> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment (Allows to take beta blockers or digoxin);
- Active severe clinical infections (>NCI-CTCAE 3.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive). Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative;
- History of allogeneic organ transplantation;
- Patients with bleeding tendency or coagulation disorders, (14 days before randomization must meet: INR is within the normal range without the use of anticoagulants);
- In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment);
- Those who have received live vaccination within 4 weeks before the start of treatment;
- Patients requiring renal dialysis;
- Those who had suffered from tumors other than small cell lung cancer within 5 years before being enrolled in this study. Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor;
- Arteriovenous thrombosis events occurred within one year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism, etc.;
- Pulmonary hemorrhage ≥ CTCAE grade 2 occurred within 4 weeks before the first use of the study drug;
- Bleeding from other parts of CTCAE Grade 3 or higher within 4 weeks before the first use of the study drug, including the following conditions: local active ulcer lesions and fecal occult blood (+ +); patients with a history of melena and hematemesis within 2 months; researcher People who think that massive gastrointestinal bleeding may occur;
- Severe unhealed wounds, ulcers or fractures;
- Uncorrected dehydration;
- Patients who are pregnant or breastfeeding;
- Drug abuse and medical, psychological or social conditions may interfere with patient participation in research or have an impact on the evaluation of research results;
- Known or suspected allergy to the test drug or any drug related to the test given;
- Any unstable conditions may endanger the safety of patients and affect their compliance with research;
- Patients with poor compliance;
- Researchers think it is inappropriate to participate in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Toripalimab Combined With Anlotinib, Etoposide and Platinum
Toripalimab 240mg,d1,q3w+Anlotinib 12mg/d,d1-14,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 or Carboplatin AUC=5, d1, q3w,4-6 cycles in total.
After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Toripalimab 240mg,d1,q3w+Anlotinib 12mg/d, was taken orally for 2 weeks and stopped for 1 week until the disease progressed.
|
Toripalimab 240mg,ivgtt,d1,q3w.
Other Names:
Anlotinib 12 mg/d,d1-14,q3w,4-6 cycles in total.
In maintenance treatment period, Anlotinib 12 mg/d,d1,Oral for 2 weeks and stop for 1 week.
Other Names:
75mg/m2,d1,q3w,4-6 cycles in total.
Other Names:
AUC=5,d1,q3w,4-6 cycles in total.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: up to 2 years
|
Defined as the time interval from randomization to death.
If the patient continues to survive or his life or death is unknown, the date of death will be reviewed using the latest point in time when the patient is still alive.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate(ORR)
Time Frame: up to 2 years
|
It is defined as the number of cases achieving CR, or PR, as a percentage of patients with evaluable efficacy.
Disease remission and progress will be evaluated based on RECIST standards.
|
up to 2 years
|
Disease control rate(DCR)
Time Frame: up to 2 years
|
The percentage of cases that achieved remission (PR+CR) and stable disease (SD) after treatment accounted for the number of evaluable cases.
In short, DCR=CR+PR+SD.
And the RECIST standard is to maintain at least 4 weeks.
|
up to 2 years
|
Progress Free Survival(PFS)
Time Frame: up to 2 years
|
It is defined as the time interval from randomization of patients to disease progression or death, whichever comes first.
There was no progress or the time of disease progression was not recorded when the trial was withdrawn, and the date of the last examination was used as the end date.
|
up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event (AE)
Time Frame: up to 2 years
|
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dong Wang, PH.D, Daping Hospital, Third Military Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
January 27, 2021
First Submitted That Met QC Criteria
January 27, 2021
First Posted (Actual)
February 1, 2021
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 8, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALT-SCLC-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
Clinical Trials on Toripalimab
-
Mabwell (Shanghai) Bioscience Co., Ltd.Not yet recruitingAdvanced Urothelial CarcinomaChina
-
Henan Cancer HospitalUnknownEsophageal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityThe First Affiliated Hospital of Guangzhou Medical University; Guangzhou Panyu...RecruitingStudy of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent ChemoradiotherapySmall Cell Lung Cancer Limited StageChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHead and Neck Squamous Cell CarcinomasChina
-
Shanghai Junshi Bioscience Co., Ltd.Not yet recruitingMelanoma | Breast Cancer | Lung CanceChina
-
Zhejiang Genfleet Therapeutics Co., Ltd.CompletedAdvanced Solid TumorChina, Australia
-
Fudan UniversityUnknownMelanoma Stage IIIB-IVChina
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingLimited-stage Small Cell Lung Cancer (LS-SCLC)China, Taiwan, Georgia, United States
-
Tianjin Medical University Cancer Institute and...Not yet recruiting
-
Qianfoshan HospitalRecruiting