SCLC, Extensive StageNCT04731909
Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer
A study testing Toripalimab, Anlotinib and Cisplatin in people with SCLC, Extensive Stage and Lung Cancer, run by Third Military Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Extensive Stage, Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- Toripalimab, Anlotinib and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dong Wang, PH.D, +862368757181, dongwang64@hotmail.com
Dong Wang, PH.D
About this study
Official title: 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.
- Conditions
- SCLC, Extensive Stage, Lung Cancer, Small Cell Lung Cancer
- Being tested
- Toripalimab, Anlotinib, Cisplatin, Carboplatin
- Keywords
- Anti-PD-1, Anti-angiogenesis, chemotherapy
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Toripalimab Injection, Teruipuli dankang Zhusheye, TuoYI, JS001
Toripalimab 240mg,ivgtt,d1,q3w.
AnlotinibDrug
Also called Anlotinib Hydrochloride Capsules, FuKeWei
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.
CisplatinDrug
Also called Cisplatin injection
75mg/m2,d1,q3w,4-6 cycles in total.
CarboplatinDrug
Also called Carboplatin injection
AUC=5,d1,q3w,4-6 cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Combined With Anlotinib, Etoposide and Platinum | Experimental | 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. Receives: Drug: Toripalimab; Drug: Anlotinib; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
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.
Measured: up to 2 years
Secondary outcomes (3)
Objective response rate(ORR)
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.
Measured: up to 2 years
Disease control rate(DCR)
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.
Measured: up to 2 years
Progress Free Survival(PFS)
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Oct 2018
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wang, Third Military Medical University
- Investigators
- Dong Wang, PH.D, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731909
- Sponsor's protocol ID
- ALT-SCLC-02
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04731909
- Acronym / sponsor ID
- ALT-SCLC-02
- Conditions
- SCLC, Extensive Stage, Lung Cancer, Small Cell Lung Cancer
- Keywords
- Anti-PD-1, Anti-angiogenesis, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Combined With Anlotinib, Etoposide and Platinum | Experimental | Drug: Toripalimab, Drug: Anlotinib, Drug: Cisplatin, Drug: CarboplatinToripalimab 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabAlso: Toripalimab Injection, Teruipuli dankang Zhusheye, TuoYI, JS001Toripalimab 240mg,ivgtt,d1,q3w. | Drug | Toripalimab Combined With Anlotinib, Etoposide and Platinum |
| AnlotinibAlso: Anlotinib Hydrochloride Capsules, FuKeWeiAnlotinib 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. | Drug | Toripalimab Combined With Anlotinib, Etoposide and Platinum |
| CisplatinAlso: Cisplatin injection75mg/m2,d1,q3w,4-6 cycles in total. | Drug | Toripalimab Combined With Anlotinib, Etoposide and Platinum |
| CarboplatinAlso: Carboplatin injectionAUC=5,d1,q3w,4-6 cycles in total. | Drug | Toripalimab Combined With Anlotinib, Etoposide and Platinum |
Primary outcome
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.
3 secondary outcomes
Objective response rate(ORR)
Time frame: up to 2 years
Disease control rate(DCR)
Time frame: up to 2 years
Progress Free Survival(PFS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Wang, PH.D principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toripalimab, Anlotinib and Cisplatin in people with SCLC, Extensive Stage and Lung Cancer, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wang, PH.D (86-23-68757181, dongwang64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.