Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Carboplatin

Antibodies

Antibodies, Monoclonal

Etoposide

Etoposide phosphate

Immunoglobulins

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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)

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)

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)

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.

TQB2450

a multi-target receptor tyrosine kinase inhibitor

Anlotinib

Etoposide is a cell cycle-specific antitumor drug

Carboplatin is cell cycle nonspecific antitumor drug

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

TQB2450（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)

Anlotinib（blank)

Ying Cheng, doctor

Junbin Wang

Haohui Fang, Bachelor

Haohui Fang

Kangsheng Gu, Doctor

Kangsheng Gu

Hui Zhao

Baolan Li, doctor

Baolan Li

Jinhuo Lai

Wu Zhuang

Yixin Wan

Junnian Shi

Shihong Wei

Jianxing He

Lizhu Lin

Shubin Wang

Hualin Chen

Qitao Yu

Xianwei Ye

Haifeng Lin

Yan Zhang

Min Zhao

Yan Yu

Qiming Wang

Yanhua Xu

Jianhua Chen

Jiashu Li

Ying Cheng, Doctor

Ying Cheng

Yang Zhang

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.

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)

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

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

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.

Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .

Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

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.

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.

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.

Spots Global Cancer Trial Database for anlotinib（blank)