A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)
A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy
1 other identifier
interventional
315
1 country
36
Brief Summary
This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2020
Longer than P75 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedStudy Start
First participant enrolled
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 31, 2022
March 1, 2022
2.5 years
March 25, 2020
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
up to 33 months
Secondary Outcomes (9)
PFS evaluated by Investigator
up to 33 months
Overall survival (OS)
up to 5 years
Overall response rate (ORR)
up to 33 months
Disease control rate（DCR）
up to 33 months
Duration of response（DOR）
up to 33 months
- +4 more secondary outcomes
Study Arms (3)
TQB2450+Anlotinib
EXPERIMENTALTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
TQB2450+Anlotinib(blank)
EXPERIMENTALTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, 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)
PLACEBO COMPARATORTQB2450 0 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 0 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Interventions
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.
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
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)
Eligibility Criteria
You may qualify if:
- years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.
- At least has one measurable lesion before radiotherapy.
- At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.
- Adequate laboratory indicators.
- No pregnant or breastfeeding women, and a negative pregnancy test.
- Understood and signed an informed consent form.
You may not qualify if:
- Squamous cell carcinoma meets following conditions should be excluded:
- Cavernous lung cancer.
- Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration.
- Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.
- Severe hypersensitivity occurs after administration of other monoclonal antibodies.
- Diagnosed and/or treated additional malignancy within 5 years with the exception of cured basal cell carcinoma of skin ,carcinoma in situ of prostate,and carcinoma in situ of cervix.
- Pathologically confirmed mixed small cell and non-small cell lung cancer.
- EGFR gene mutations.
- Has any active autoimmune disease or history of autoimmune disease.
- After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.
- Has ≥grade 2 pneumonia.
- Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \> 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
- Has multiple factors affecting oral medication.
- Has active bleeding or a persistent decrease in hemoglobin.
- Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Anhui Chest Hospital
Hefei, Anhui, 230000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512025, China
Affiliated Hospital of Guangdong Medical University
Zhangjiang, Guangdong, 524000, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, 519000, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530200, China
The Fourth Hospital of Hebei medical University
Shijiazhuang, Hebei, 050019, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Anyang Cancer Hospital
Anyang, Henang, 455000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Huaian First People's Hospital
Huai'an, Jiangsu, 223300, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210029, China
Jiangsu People's Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330012, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
Xijing Hospital of Airforce Medical University
Xi’an, Shanxi, 710000, China
First Affiliated Hospital of Xi'anjiantong University
Xi’an, Shanxi, 710061, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The first Hospital of Zhengjiang Province
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Zhejiang People's Hospital
Hangzhou, Zhejiang, 310014, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
Taizhou Central Hospital
Taizhou, Zhejiang, 318000, China
Related Publications (1)
Dong B, Chen L, Pang Q, Jiang O, Ge H, Cheng Y, Zhou R, Meng X, Li J, Zhu X, Wang X, Cao Q, Ji Y, Chen M. TQB2450 with or without anlotinib as maintenance treatment in subjects with locally advanced/unresectable non-small cell lung cancer that have not progressed after prior concurrent/sequential chemoradiotherapy (R-ALPS): study protocol for a randomized, double-blind, placebo-controlled, multicenter phase III trial. Transl Lung Cancer Res. 2024 Oct 31;13(10):2828-2837. doi: 10.21037/tlcr-24-362. Epub 2024 Oct 28.
PMID: 39507039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2020
First Posted
March 30, 2020
Study Start
May 27, 2020
Primary Completion
December 1, 2022
Study Completion
March 1, 2025
Last Updated
March 31, 2022
Record last verified: 2022-03