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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325763
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Stage III Non-small-cell Lung Cancer Drug: TQB2450 Drug: Anlotinib Drug: TQB2450(blank) Drug: Anlotinib(blank) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


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: 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
a multi-target receptor tyrosine kinase inhibitor

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: TQB2450(blank)
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day

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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall response rate (ORR) [ Time Frame: up to 33 months ]
    Percentage of participants achieving complete response (CR) and partial response (PR).

  4. 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).

  5. Duration of response(DOR) [ Time Frame: up to 33 months ]
    The time when the participants first achieved complete or partial remission to disease progression.

  6. PFS rate at month 6 [ Time Frame: up to 6 months ]
    The percentage of PFS at month 6

  7. PFS rate at month 12 [ Time Frame: up to 12 months ]
    The percentage of PFS at month 12

  8. 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).

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325763


Contacts
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Contact: Ming Chen 0571-88122508 chenming@zjcc.org.cn

Locations
Show Show 35 study locations
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04325763    
Other Study ID Numbers: TQB2450-III-05
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms