Toripalimab Combined With Anlotinib, Etoposide and Platinum in the Treatment of Extensive-stage Small Cell Lung Cancer

NCT04731909 | Unknown

• 1 other identifier: ALT-SCLC-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCLC, Extensive Stage; Lung Cancer; Small Cell Lung Cancer

Keywords

Anti-PD-1; Anti-angiogenesis; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years

Secondary Outcomes (3)

• Objective response rate(ORR)

  up to 2 years

• Disease control rate(DCR)

  up to 2 years

• Progress Free Survival(PFS)

  up to 2 years

Other Outcomes (1)

• Adverse Event (AE)

  up to 2 years

Study Arms (1)

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.

Drug: Toripalimab; Drug: Anlotinib; Drug: Cisplatin; Drug: Carboplatin

Interventions

Toripalimab DRUG

Toripalimab 240mg,ivgtt,d1,q3w.

Also known as: Toripalimab Injection, Teruipuli dankang Zhusheye, TuoYI, JS001

Toripalimab Combined With Anlotinib, Etoposide and Platinum

Anlotinib DRUG

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.

Also known as: Anlotinib Hydrochloride Capsules, FuKeWei

Toripalimab Combined With Anlotinib, Etoposide and Platinum

Cisplatin DRUG

75mg/m2,d1,q3w,4-6 cycles in total.

Also known as: Cisplatin injection

Toripalimab Combined With Anlotinib, Etoposide and Platinum

Carboplatin DRUG

AUC=5,d1,q3w,4-6 cycles in total.

Also known as: Carboplatin injection

Toripalimab Combined With Anlotinib, Etoposide and Platinum

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

toripalimab; anlotinib; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Dong Wang, PH.D

  Daping Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, PH.D

CONTACT

86-23-68757181; dongwang64@hotmail.com

Dong Wang, PH.D

CONTACT

13678428206; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: October 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2023
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)