A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701)

January 18, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Double-blind, Controlled, Multicenter Phase III Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer

A randomized, double-blind, controlled, multicenter phase III study of TQB2450 or placebo combined with Anlotinib, etoposide and carboplatin versus Etoposide and Carboplatin in subjects with extensive small cell lung cancer. The primary outcome measures include PFS and OS. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1:1 to the experimental arms and the control arm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

738

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Principal Investigator:
          • Junbin Wang
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230001
        • Anhui Chest Hospital
        • Principal Investigator:
          • Haohui Fang
        • Contact:
      • Hefei, Anhui, China, 230001
        • The First Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • Kangsheng Gu
        • Contact:
      • Hefei, Anhui, China, 230001
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Hui Zhao
    • Beijing
      • Beijing, Beijing, China, 101149
        • Beijing Chest Hospital,Capital Medical University
        • Principal Investigator:
          • Baolan Li
        • Contact:
          • Baolan Li, doctor
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Jinhuo Lai
        • Contact:
      • Fuzhou, Fujian, China, 350011
        • Fujian Provincial Cancer Hospital
        • Principal Investigator:
          • Wu Zhuang
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou University Second Hospital
        • Contact:
        • Principal Investigator:
          • Yixin Wan
        • Principal Investigator:
          • Junnian Shi
      • Lanzhou, Gansu, China, 730050
        • Gansu Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Shihong Wei
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Jianxing He
        • Contact:
      • Guangzhou, Guangdong, China, 510405
        • The Fiest Affiliated Hospital of Guanghzou University of Chinese Medicine
        • Principal Investigator:
          • Lizhu Lin
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
        • Contact:
        • Principal Investigator:
          • Shubin Wang
      • Zhanjiang, Guangdong, China, 524000
        • Affiliated Hospital of Guangdong Medical University
        • Principal Investigator:
          • Hualin Chen
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Xianwei Ye
    • Hainan
      • Haikou, Hainan, China, 570100
        • The Second Affiliated Hospital of Hainan Medical University
        • Principal Investigator:
          • Haifeng Lin
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Shijiazhuang First Hospital
        • Principal Investigator:
          • Yan Zhang
        • Contact:
      • Shijiazhuang, Hebei, China, 050048
        • Hebei Chest Hospital
        • Contact:
        • Principal Investigator:
          • Min Zhao
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin medical university cancer hospital
        • Principal Investigator:
          • Yan Yu
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
    • Hubei
      • Jinzhou, Hubei, China, 434020
        • Jinzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Yanhua Xu
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer hospital
        • Contact:
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222000
        • The First People's Hospital of Lianyungang
        • Contact:
        • Principal Investigator:
          • Jiashu Li
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin cancer hospital
        • Principal Investigator:
          • Ying Cheng
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • The Second Hospital of Dalian Medical University
        • Contact:

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:

  • 1. Pathologically confirmed extensive small cell Lung cancer; 2. Has not received systematic treatment for extensive small cell lung cancer; 3. Has received radiotherapy and chemotherapy for limited stage SCLC must have received radical treatment, and has at least 6 months of no treatment interval from the last treatment to the diagnosis of extensive SCLC; 4. Has measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5. 18 and 75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization; 8. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1. Has prior therapy with anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L1; 2. Has central nervous system metastasis and/or cancerous meningitis; 3. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix; 4. Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc; 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; 6. Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to randomization ≥1 week; 7. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear; 8. Within 2 months prior to initial administration, subjects with evidence or history of bleeding tendency, regardless of severity; A history of hemoptysis (defined as blood bright red or 1/2 teaspoon) or an unhealed wound, ulcer, or fracture in the 2 weeks prior to initial administration; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 1; 10.Has major surgical procedure、biopsy or obvious traumatic injury within 28 days before randomization; 11. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism; 12.Has drug abuse history that unable to abstain from or mental disorders; 13. Has any severe and/or uncontrolled disease; 14. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.; 15. Severe hypersensitivity occurs after administration of other monoclonal antibodies; 16. Active autoimmune diseases requiring systemic treatment occurred within 2 years prior to first administration ; 17. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration; 18. Has participated in other anticancer drug clinical trials within 4 weeks; 19. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2450+Anlotinib+ etoposide + carboplatin
Induced stage：TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3）+Carboplatin（AUC 5 mg/mL/min IV on Day 1（ maximum dosage: 800 mg）） maintenance stage：TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Drug: Anlotinib
a multi-target receptor tyrosine kinase inhibitor
Drug: TQB2450
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Drug: Etoposide
Etoposide is a cell cycle-specific antitumor drug
Drug: Carboplatin
Carboplatin is cell cycle nonspecific antitumor drug
Experimental: TQB2450（blank）+Anlotinib+ etoposide + carboplatin
Induced stage：TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) +Etoposide (100mg/m2 IV continuously on Day 1,2 and 3）+ Carboplatin（AUC 5 mg/mL/min IV on Day 1（ maximum dosage: 800 mg）） maintenance stage：TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Drug: Anlotinib
a multi-target receptor tyrosine kinase inhibitor
Drug: Etoposide
Etoposide is a cell cycle-specific antitumor drug
Drug: Carboplatin
Carboplatin is cell cycle nonspecific antitumor drug
Drug: TQB2450（blank）
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
Active Comparator: TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin
Induced stage：TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib (blank) capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) +Etoposide (100mg/m2 IV continuously on Day 1,2 and 3）+Carboplatin（AUC 5 mg/mL/min IV on Day 1（ maximum dosage: 800 mg）） maintenance stage：TQB2450 (blank) 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Anlotinib capsules (blank) 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Drug: Etoposide
Etoposide is a cell cycle-specific antitumor drug
Drug: Carboplatin
Carboplatin is cell cycle nonspecific antitumor drug
Drug: TQB2450（blank）
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
Drug: Anlotinib（blank)
Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 24 months
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
up to 24 months
Progression free survival (PFS)
Time Frame: up to 12 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: up to 12 months
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .
up to 12 months
Disease control rate (DCR)
Time Frame: up to 12 months
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
up to 12 months
Duration of response（DOR）
Time Frame: up to 12 months
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
up to 12 months
PFS rate of 6 and 12 months progression-free survival
Time Frame: up to 12 months
PFS rate of progression-free survival at 6 and 12 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 and 12 months after randomization.
up to 12 months
OS rate of 12 and 18 months total survival
Time Frame: up to 12 months
Total survival OS rate at 12 and 18 months: the proportion of subjects who died of any cause at 12 and 18 months after randomization.
up to 12 months
Quality of life score
Time Frame: up to 12 months
up to 12 months
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time Frame: up to 24 months
Security Index
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 18, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2450-Ⅲ-04

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.

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