Extensive Small Cell Lung CancerPhase 3NCT04234607
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 Phase 3 study testing TQB2450, Anlotinib and Etoposide in people with Extensive Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 26 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Small Cell Lung Cancer
- What is being tested?
- TQB2450, Anlotinib and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 738 participants
- Where
- 26 sitesChina
- Study dates
- Jan 2020to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Beijing chest hospital，capital medical university
Beijing, Beijing Municipality, 101149
Baolan Li, doctor
Baolan Li
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Junbin Wang, 0552-3074480, bbmcwjb@163.com
Junbin Wang
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, Doctor, 0431-85873390, jl.cheng@163.com
Ying Cheng
Hunan Cancer Hospital
Changsha, Hunan, 410006
Jianhua Chen, 0731-89762220, cjh_1000@163.com
Jianhua Chen
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Yang Zhang, 0411-84671291, zydl@medmail.com.cn
Yang Zhang
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jinhuo Lai, 0591-86218442, ljh2252@hotmail.com
Jinhuo Lai
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350011
Wu Zhuang, 0591-62002062, zhuangwu2008@126.com
Wu Zhuang
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Jianxing He, 020-83062807, hejx@vip.163.com
Jianxing He
The Fiest Affiliated Hospital of Guanghzou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Lizhu Lin, 020-36596356, lizhulin903@21cn.com
Lizhu Lin
Guizhou Provincial people's Hospital
Guiyang, Guizhou, 550002
Xianwei Ye, 0851-8560232, yxw1205@163.com
Xianwei Ye
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570100
Haifeng Lin, 0898-66809162, 13322060949@163.com
Haifeng Lin
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Yan Yu, 0451-86298303, gpyuyan@163.com
Yan Yu
Anhui chest hospital
Hefei, Anhui, 230001
Haohui Fang, Bachelor, 0551-63615328, fanghh88@163.com
Haohui Fang
AnHui Provincial Hospital
Hefei, Anhui, 230001
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Kangsheng Gu, Doctor, 0551-62923093, 13805692145@153.com
Kangsheng Gu
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Hui Zhao, 0551-65997169, zhaohuichenxi@126.com
Hui Zhao
Jinzhou Central Hospital
Jinzhou, Hubei, 434020
Yanhua Xu, 0716-8881888, xuyanhua339@126.com
Yanhua Xu
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Yixin Wan, 0931-8942347, 101937415@qq.com
Yixin Wan
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Shihong Wei, 0931-2302833, weishihong100@163.com
Shihong Wei
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
Jiashu Li, 025-85605031, ljssm1118@sina.com
Jiashu Li
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530000
Qitao Yu, 0771-12580, yqt178@163.com
Qitao Yu
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Shubin Wang, 0755-83923333-2501, Wangshubin2013@163.com
Shubin Wang
Shijiazhuang First Hospital
Shijiazhuang, Hebei, 050011
Yan Zhang, 0311-86907259, 13315978336@163.com
Yan Zhang
Hebei Chest Hospital
Shijiazhuang, Hebei, 050048
Min Zhao, 0311-86911008, z-mxk1067@126.com
Min Zhao
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Hualin Chen, 0759-2387458, 3549509@qq.com
Hualin Chen
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang, 0371-65588421, qimingwang1006@126.com
Qiming Wang
About this study
Official title: 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.
- Conditions
- Extensive Small Cell Lung Cancer
- Being tested
- TQB2450, Anlotinib, Etoposide, Carboplatin, TQB2450（blank）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450Drug
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.
AnlotinibDrug
a multi-target receptor tyrosine kinase inhibitor
EtoposideDrug
Etoposide is a cell cycle-specific antitumor drug
CarboplatinDrug
Carboplatin is cell cycle nonspecific antitumor drug
TQB2450（blank）Drug
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
Anlotinib（blank)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)
| Study group | Role | What they receive |
|---|---|---|
| TQB2450+Anlotinib+ etoposide + carboplatin | Experimental | 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) Receives: Drug: TQB2450; Drug: Anlotinib; Drug: Etoposide; Drug: Carboplatin |
| TQB2450（blank）+Anlotinib+ etoposide + carboplatin | Experimental | 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) Receives: Drug: Anlotinib; Drug: Etoposide; Drug: Carboplatin; Drug: TQB2450（blank） |
| TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin | Active comparator | 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) Receives: Drug: Etoposide; Drug: Carboplatin; Drug: TQB2450（blank）; Drug: Anlotinib（blank) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 12 months
Overall survival (OS)
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.
Measured: up to 24 months
Secondary outcomes (7)
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .
Measured: up to 12 months
Disease control rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: up to 12 months
Duration of response（DOR）
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.
Measured: up to 12 months
PFS rate of 6 and 12 months progression-free survival
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.
Measured: up to 12 months
OS rate of 12 and 18 months total survival
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.
Measured: up to 12 months
Quality of life score
Measured: up to 12 months
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Security Index
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 738 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234607
- Sponsor's protocol ID
- TQB2450-Ⅲ-04
- Status last verified
- Aug 2019
- First submitted
- 16 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38992123
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04234607
- Acronym / sponsor ID
- TQB2450-Ⅲ-04
- Conditions
- Extensive Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 738 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQB2450+Anlotinib+ etoposide + carboplatin | Experimental | Drug: TQB2450, Drug: Anlotinib, Drug: Etoposide, Drug: CarboplatinInduced 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) |
| TQB2450（blank）+Anlotinib+ etoposide + carboplatin | Experimental | Drug: Anlotinib, Drug: Etoposide, Drug: Carboplatin, Drug: TQB2450（blank）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) |
| TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin | Active comparator | Drug: Etoposide, Drug: Carboplatin, Drug: TQB2450（blank）, Drug: Anlotinib（blank)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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2450TQB2450 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 | TQB2450+Anlotinib+ etoposide + carboplatin |
| Anlotiniba multi-target receptor tyrosine kinase inhibitor | Drug | TQB2450+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib+ etoposide + carboplatin |
| EtoposideEtoposide is a cell cycle-specific antitumor drug | Drug | TQB2450+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin |
| CarboplatinCarboplatin is cell cycle nonspecific antitumor drug | Drug | TQB2450+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin |
| TQB2450（blank）Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day | Drug | TQB2450（blank）+Anlotinib+ etoposide + carboplatin, TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin |
| 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) | Drug | TQB2450（blank）+Anlotinib（blank）+ etoposide + carboplatin |
Primary outcome
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.
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.
7 secondary outcomes
Overall response rate (ORR)
Time frame: up to 12 months
Disease control rate (DCR)
Time frame: up to 12 months
Duration of response（DOR）
Time frame: up to 12 months
PFS rate of 6 and 12 months progression-free survival
Time frame: up to 12 months
OS rate of 12 and 18 months total survival
Time frame: up to 12 months
Quality of life score
Time frame: up to 12 months
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 38992123Cheng 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.
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Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2450, Anlotinib and Etoposide in people with Extensive Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Cheng, doctor (0431-85873390, jl.cheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.