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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)

NCT ID: NCT04234607

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

738 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Extensive Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

TQB2450

Intervention Type DRUG

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.

Anlotinib

Intervention Type DRUG

a multi-target receptor tyrosine kinase inhibitor

Etoposide

Intervention Type DRUG

Etoposide is a cell cycle-specific antitumor drug

Carboplatin

Intervention Type DRUG

Carboplatin is cell cycle nonspecific antitumor drug

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)

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

a multi-target receptor tyrosine kinase inhibitor

Etoposide

Intervention Type DRUG

Etoposide is a cell cycle-specific antitumor drug

Carboplatin

Intervention Type DRUG

Carboplatin is cell cycle nonspecific antitumor drug

TQB2450（blank）

Intervention Type DRUG

Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

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)

Group Type ACTIVE_COMPARATOR

Etoposide

Intervention Type DRUG

Etoposide is a cell cycle-specific antitumor drug

Carboplatin

Intervention Type DRUG

Carboplatin is cell cycle nonspecific antitumor drug

TQB2450（blank）

Intervention Type DRUG

Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

Anlotinib（blank)

Intervention Type DRUG

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)

Interventions

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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.

Intervention Type DRUG

Anlotinib

a multi-target receptor tyrosine kinase inhibitor

Intervention Type DRUG

Etoposide

Etoposide is a cell cycle-specific antitumor drug

Intervention Type DRUG

Carboplatin

Carboplatin is cell cycle nonspecific antitumor drug

Intervention Type DRUG

TQB2450（blank）

Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Anhui chest hospital

Hefei, Anhui, China

Site Status

AnHui Provincial Hospital

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Beijing chest hospital，capital medical university

Beijing, Beijing Municipality, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Site Status

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The Fiest Affiliated Hospital of Guanghzou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Site Status

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Site Status

Guizhou Provincial people's Hospital

Guiyang, Guizhou, China

Site Status

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status

Shijiazhuang First Hospital

Shijiazhuang, Hebei, China

Site Status

Hebei Chest Hospital

Shijiazhuang, Hebei, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Jinzhou Central Hospital

Jinzhou, Hubei, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Site Status

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Countries

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China

Central Contacts

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Ying Cheng, doctor

Role: CONTACT

[email protected]
0431-85873390

Facility Contacts

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Junbin Wang

Role: primary

[email protected]
0552-3074480

Haohui Fang, Bachelor

Role: primary

[email protected]
0551-63615328

Kangsheng Gu, Doctor

Role: primary

[email protected]
0551-62923093

Hui Zhao

Role: primary

[email protected]
0551-65997169

Baolan Li, doctor

Role: primary

Jinhuo Lai

Role: primary

[email protected]
0591-86218442

Wu Zhuang

Role: primary

[email protected]
0591-62002062

Yixin Wan

Role: primary

[email protected]
0931-8942347

Shihong Wei

Role: primary

[email protected]
0931-2302833

Jianxing He

Role: primary

[email protected]
020-83062807

Lizhu Lin

Role: primary

[email protected]
020-36596356

Shubin Wang

Role: primary

[email protected]
0755-83923333-2501

Hualin Chen

Role: primary

[email protected]
0759-2387458

Qitao Yu

Role: primary

[email protected]
0771-12580

Xianwei Ye

Role: primary

[email protected]
0851-8560232

Haifeng Lin

Role: primary

[email protected]
0898-66809162

Yan Zhang

Role: primary

[email protected]
0311-86907259

Min Zhao

Role: primary

[email protected]
0311-86911008

Yan Yu

Role: primary

[email protected]
0451-86298303

Qiming Wang

Role: primary

[email protected]
0371-65588421

Yanhua Xu

Role: primary

[email protected]
0716-8881888

Jianhua Chen

Role: primary

[email protected]
0731-89762220

Jiashu Li

Role: primary

[email protected]
025-85605031

Ying Cheng, Doctor

Role: primary

[email protected]
0431-85873390

Yang Zhang

Role: primary

[email protected]
0411-84671291

References

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Cheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, Huang C, Wei S, Sun H, Li X, Yu Y, Lai J, Yang H, Fang H, Chen H, Zhang P, Gu K, Wang Q, Shi J, Yi T, Xu X, Ye X, Wang D, Xie C, Liu C, Zheng Y, Lin D, Zhuang W, Lu P, Yu G, Li J, Gu Y, Li B, Wu R, Jiang O, Wang Z, Wu G, Lin H, Zhong D, Xu Y, Shu Y, Wu D, Chen X, Wang J, Wang M, Yang R. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30(10):2967-2976. doi: 10.1038/s41591-024-03132-1. Epub 2024 Jul 11.

Reference Type DERIVED
PMID: 38992123 (View on PubMed)

Other Identifiers

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TQB2450-Ⅲ-04

Identifier Type: -

Identifier Source: org_study_id

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