Clinical Trials /

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

NCT04325763

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)
  • 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 IDs

  • ORG STUDY ID: TQB2450-III-05
  • NCT ID: NCT04325763

Conditions

  • Stage III Non-small-cell Lung Cancer

Interventions

DrugSynonymsArms
TQB2450TQB2450+Anlotinib
AnlotinibTQB2450+Anlotinib
TQB2450(blank)TQB2450(blank)+Anlotinib(blank)
Anlotinib(blank)TQB2450(blank)+Anlotinib(blank)

Purpose

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 Arms

NameTypeDescriptionInterventions
TQB2450+AnlotinibExperimentalTQB2450 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
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
  • Anlotinib(blank)
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).
  • TQB2450(blank)
  • Anlotinib(blank)

Eligibility 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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Last Updated

March 26, 2020