Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

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

Vasoconstrictor Agents

Respiratory System Agents

Hematinics

Carboplatin

Etoposide

Epinephrine

Immunomodulating Agents

Etoposide phosphate

Liver Extracts

Racepinephrine

Epinephryl borate

Enzyme Inhibitors

Administration regimen: adebelizumab 1200mg, IV, Q3W+ carboplatin AUC 5 d1+ etoposide 100mg/m2 D1, 2, 3; 21 days is a treatment cycle. After 4-6 cycles, patients with imaging evaluation CR/PR/SD (according to tumor RECIST1.1 standard) receive adebelizumab maintenance therapy and radiotherapy at the same time. Patients with imaging evaluation PD (according to tumor RECIST1.1 standard) can receive adebelizumab maintenance therapy combined with radiotherapy according to the clinical practice, or they can change other treatment schemes and continue to follow up.

After the induction treatment, the participants will continue to receive adebelizumab (20mg/kg, IV, Q3W) combined with concurrent radiotherapy (conventional radiotherapy SBRT chest lesions (2Gy\*25f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ suprarenal gland (3Gy\*10-15f)/ liver (3YX).

Eligible patients will receive the following treatment schemes: adebelizumab+carboplatin+etoposide, with one treatment cycle every three weeks. After 4-6 cycles, adebelizumab maintenance therapy combined with concurrent radiotherapy will be given, and conventional radiotherapy will be given to chest lesions (2Gy\*(20-30)f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ adrenal gland. Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum, and immunotherapy is given 1-2 weeks after radiotherapy. Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy.

Adebelizumab+Carboplatin+Etoposide+Concurrent Radiotherapy

Jiandong Zhang

To observe the efficacy and safety of adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy in the treatment of newly diagnosed extensive small cell lung cancer.

This study is a one-arm, multi-center and exploratory study. Eligible patients will receive the following treatment schemes: adebelizumab+carboplatin+etoposide, with one treatment cycle every three weeks. After 4-6 cycles, adebelizumab maintenance therapy combined with concurrent radiotherapy will be given, and conventional radiotherapy will be given to chest lesions (2Gy\*(20-30)f), brain (3Gy\*10f)/ bone (3Gy\*10f)/ adrenal gland. Immunotherapy is suspended during radiotherapy for chest lesions and lymph nodes in mediastinum, and immunotherapy is given 1-2 weeks after radiotherapy. Radiotherapy for other metastatic lesions can be carried out simultaneously with immunotherapy.

Research population: patients with extensive small cell lung cancer diagnosed by histopathology or cytology, both male and female, aged 18-75 years old, who have not received systemic treatment for small cell lung cancer before. 51 patients are planned to be enrolled.

Main research end point： PFS(RECIST v1.1 standard) evaluated by researchers. Secondary end point

Key secondary study endpoints:

The incidence of adverse reactions above grade 3 in patients evaluated according to CTCAE5.0 version 5.0.

Other secondary study endpoints:

OS； ORR(RECIST v1.1 standard) evaluated by researchers; DoR； evaluated by the researcher; DCR； assessed by the researcher; PFS rate at 6 months and 1 year OS rate at 1 year and 2 years. The end point of exploratory research Explore the biomarker related to curative effect.

Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC

A Single-arm, Multi-center and Exploratory Study of Adebelizumab Combined With Chemotherapy and Sequential Adebelizumab Combined With Radiotherapy in the Treatment of Newly Diagnosed Extensive Small Cell Lung Cancer

To explore the progression-free survival (PFS) and overall survival (OS) of patients with different types (SCLC-A/N/Y/P) of extensive small cell lung cancer treated by adebelizumab combined with chemotherapy and sequential adebelizumab combined with radiotherapy.

The time from the beginning of randomization to the occurrence (in any way) progression or death (for any reason) of a tumor.

Time from randomization to death (for any reason). For subjects who have been lost before death, the last follow-up time is usually calculated as the time of death.

The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission and partial remission.

The percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment to the evaluable cases.

Refers to the first evaluation of the tumor as CR or PR.

Qianfoshan Hospital

Director of radiotherapy department,archiater

Amino Acids

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tyrosine Kinase 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adebelizumab Combined With Chemotherapy and Radiotherapy Treat ES-SCLC	NCT06125041	Extensive Small...	Adebelizumab+Ca...	18 Years - 75 Years	Qianfoshan Hospital
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)	NCT04234607	Extensive Small...	TQB2450 Anlotinib Etoposide Carboplatin TQB2450（blank） Anlotinib（blank...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for extensive small cell lung cancer