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

March 15, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Chest Hospital
        • Contact:
        • Principal Investigator:
          • Xuhong Min
    • Beijing
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • LI Zhang, master
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yue Xie, Master
      • Chongqing, Chongqing, China, 400000
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Yuxi Zhu, Doctor
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jiangcheng Li
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Ming Chen, Doctor
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Yong Bao, Doctor
      • Shaoguan, Guangdong, China, 512025
        • Not yet recruiting
        • Yuebei People's Hospital
        • Contact:
          • Suming Pan, Master
          • Phone Number: 0751-6913383
        • Principal Investigator:
          • Suming Pan, Master
      • Zhangjiang, Guangdong, China, 524000
        • Not yet recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Hualin Chen, Doctor
          • Phone Number: 0759-2387458
          • Email: 3549509@qq.com
        • Principal Investigator:
          • Hualin Chen, Doctor
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Zhigang Liu, Doctor
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Long Chen
    • Hebei
      • Shijiazhuang, Hebei, China, 050019
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Jun Wang, Doctor
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hong Ge, Doctor
    • Henang
      • Anyang, Henang, China, 455000
        • Recruiting
        • Anyang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Anping Zheng, Master
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Desheng Hu, Doctor
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Principal Investigator:
          • Rongrong Zhou, Doctor
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • peiguo cao, doctor
      • Changsha, Hunan, China, 410006
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • hui Wang, Doctor
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Not yet recruiting
        • Huaian First People's Hospital
        • Contact:
        • Principal Investigator:
          • Changhua Yu, Master
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Principal Investigator:
          • Jifeng Feng, Doctor
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu People's Hospital
        • Contact:
        • Principal Investigator:
          • Lianke Liu, Doctor
    • Jiangxi
      • Nanchang, Jiangxi, China, 330012
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
        • Principal Investigator:
          • Junhe Li, Doctor
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yufeng Cheng, Doctor
          • Phone Number: 0531-82169821
          • Email: qlcyf@163.com
        • Principal Investigator:
          • Yufeng Cheng, Doctor
    • Shanxi
      • Baoji, Shanxi, China, 721008
        • Not yet recruiting
        • Baoji Central Hospital
        • Contact:
        • Principal Investigator:
          • Yi Geng, Master
        • Principal Investigator:
          • Kai Chen, Master
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Weihua Yang, Master
          • Phone Number: 0351-4651623
          • Email: ywh1964@qq.com
        • Principal Investigator:
          • Weihua Yang, Master
      • Xi'an, Shanxi, China, 710000
        • Not yet recruiting
        • Xijing Hospital of Airforce Medical University
        • Contact:
        • Principal Investigator:
          • Lina Zhao, Doctor
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'anjiantong University
        • Contact:
        • Principal Investigator:
          • Xiaozhi Zhang, Doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin cancer hospital
        • Contact:
        • Principal Investigator:
          • Qingsong Pang, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The first Hospital of Zhengjiang Province
        • Contact:
        • Principal Investigator:
          • Sengxiang Yan, Doctor
      • Hangzhou, Zhejiang, China, 310006
        • Not yet recruiting
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Bing Xia, Doctor
      • Hangzhou, Zhejiang, China, 310013
        • Not yet recruiting
        • Zhejiang Hospital
        • Contact:
        • Principal Investigator:
          • Zhibing Wu, Doctor
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Zhejiang People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiaodong Liang, Doctor
      • Ningbo, Zhejiang, China, 315000
        • Not yet recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
        • Principal Investigator:
          • Hongcheng Wu, Master
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
        • Principal Investigator:
          • Haihua Yang, Master
      • Taizhou, Zhejiang, China, 318000
        • Not yet recruiting
        • Taizhou Central Hospital
        • Principal Investigator:
          • Shenpeng Ying
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2450+Anlotinib
TQB2450 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).
Drug: Anlotinib
a multi-target receptor tyrosine kinase inhibitor
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.
Experimental: TQB2450+Anlotinib(blank)
TQB2450 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).
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.
Drug: 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)
Placebo Comparator: TQB2450(blank)+Anlotinib(blank)
TQB2450 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).
Drug: 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)
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
Time Frame: up to 33 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS evaluated by Investigator
Time Frame: up to 33 months
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
Overall survival (OS)
Time Frame: up to 5 years
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
Overall response rate (ORR)
Time Frame: up to 33 months
Percentage of participants achieving complete response (CR) and partial response (PR).
up to 33 months
Disease control rate（DCR）
Time Frame: up to 33 months
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 33 months
Duration of response（DOR）
Time Frame: up to 33 months
The time when the participants first achieved complete or partial remission to disease progression.
up to 33 months
PFS rate at month 6
Time Frame: up to 6 months
The percentage of PFS at month 6
up to 6 months
PFS rate at month 12
Time Frame: up to 12 months
The percentage of PFS at month 12
up to 12 months
Biomarkers, such as PD-L1 expression, etc.
Time Frame: up to 33 months
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
Immunogenicity, such as the incidence of ADA
Time Frame: on day 1, 42, 105, 189 and 90 days after the last administration.
Degree of the immune response caused by the drug.
on day 1, 42, 105, 189 and 90 days after the last administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2450-III-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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