Clinical trial NCT04234607: 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)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Extensive Small Cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 12 months
measure: Overall survival (OS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 12 months
measure: Disease control rate (DCR)
timeFrame: up to 12 months
measure: Duration of response（DOR）
timeFrame: up to 12 months
measure: PFS rate of 6 and 12 months progression-free survival
timeFrame: up to 12 months
measure: OS rate of 12 and 18 months total survival
timeFrame: up to 12 months
measure: Quality of life score
timeFrame: up to 12 months
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui chest hospital
state: Anhui
city: Hefei
country: China
facility: AnHui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing chest hospital，capital medical university
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Fiest Affiliated Hospital of Guanghzou University of Chinese Medicine
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Provincial people's Hospital
state: Guizhou
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijiazhuang
country: China
facility: Shijiazhuang First Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Chest Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
Study officials:
References: