A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)

Stage III Non-small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325763
• Other study ID #: TQB2450-III-05
• Status: Recruiting
• Phase: Phase 3
• Start date: May 27, 2020
• Est. completion date: March 2025

Study information

• Verified date: March 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Ming Chen
• Phone: 0571-88122508
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: March 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy = 3 months.

2. Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.

3. At least has one measurable lesion before radiotherapy.

4. At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.

5. Adequate laboratory indicators.

6. No pregnant or breastfeeding women, and a negative pregnancy test.

7. Understood and signed an informed consent form.

Exclusion Criteria:

1. Squamous cell carcinoma meets following conditions should be excluded:

1. Cavernous lung cancer.

2. Has hemoptysis and maximum daily hemoptysis volume = 2.5ml within 1 month before the first administration.

2. 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.

3. Severe hypersensitivity occurs after administration of other monoclonal antibodies.

4. 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.

5. Pathologically confirmed mixed small cell and non-small cell lung cancer.

6. EGFR gene mutations.

7. Has any active autoimmune disease or history of autoimmune disease.

8. After the early stage of chemoradiotherapy, the treatment toxicity = grade 2 is not fully alleviated.

9. Has =grade 2 pneumonia.

10. 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.

11. Has multiple factors affecting oral medication.

12. Has active bleeding or a persistent decrease in hemoglobin.

13. Has any bleeding or bleeding events =grade 3 in the first 4 weeks before the first administration. 2.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.

14. Has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration.

15. Has received NMPA approved anti-tumor drugs or immunomodulatory drugs for systemic treatment within 2 weeks before the first administration. 16.Has a history of a hematological system transplantation or organ transplantation.

17. Has active diverticulitis?peritoneal abscess, intestinal obstruction. 18. Has any serious and/or uncontrollable disease. 19. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small-cell Lung Cancer

Intervention

Drug:
• TQB2450
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.
• Anlotinib
a multi-target receptor tyrosine kinase inhibitor
• TQB2450(blank)
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
• 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)

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henang
China	Baoji Central Hospital	Baoji	Shanxi
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital Sun Yat-Sen University	Guangzhou	Guangdong
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first Hospital of Zhengjiang Province	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang People's Hospital	Hangzhou	Zhejiang
China	Anhui Chest Hospital	Hefei	Anhui
China	Huaian First People's Hospital	Huai'an	Jiangsu
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu People's Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	Yuebei People's Hospital	Shaoguan	Guangdong
China	The Fourth Hospital of Hebei medical University	Shijiazhuang	Hebei
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Central Hospital	Taizhou	Zhejiang
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	First Affiliated Hospital of Xi'anjiantong University	Xi'an	Shanxi
China	Xijing Hospital of Airforce Medical University	Xi'an	Shanxi
China	Affiliated Hospital of Guangdong Medical University	Zhangjiang	Guangdong
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The Fifth Affiliated Hospital Sun Yat-Sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS evaluated by Investigator	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.	up to 33 months
Secondary	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.	up to 5 years
Secondary	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 33 months
Secondary	Disease control rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 33 months
Secondary	Duration of response(DOR)	The time when the participants first achieved complete or partial remission to disease progression.	up to 33 months
Secondary	PFS rate at month 6	The percentage of PFS at month 6	up to 6 months
Secondary	PFS rate at month 12	The percentage of PFS at month 12	up to 12 months
Secondary	Biomarkers, such as PD-L1 expression, etc.	Tissue samples were collected during the screening period for pd-l1 analysis. Blood samples were collected for Tumor Mutation Burden (TMB) test before enrollment (within 7 days before medication) and after exit (±3 days).	up to 33 months
Secondary	Immunogenicity, such as the incidence of ADA	Degree of the immune response caused by the drug.	on day 1, 42, 105, 189 and 90 days after the last administration.