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.
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
Drug | Synonyms | Arms |
---|
TQB2450 | | TQB2450+Anlotinib |
Anlotinib | | TQB2450+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
Name | Type | Description | Interventions |
---|
TQB2450+Anlotinib | Experimental | 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). | |
TQB2450+Anlotinib(blank) | Experimental | 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). | |
TQB2450(blank)+Anlotinib(blank) | Placebo Comparator | 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). | - 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: | Recruiting |
Lead Sponsor: | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Last Updated
July 1, 2020