A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)
- Conditions
- Stage III Non-small-cell Lung Cancer
- Interventions
- Registration Number
- NCT04325763
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 315
- 18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed unresectable (Stage III) Non-Small Cell Lung Cancer.
- At least has one measurable lesion before radiotherapy.
- At least has one type of platinum-containing chemotherapy, Absence of progression after concurrent/sequential chemoradiotherapy.
- Adequate laboratory indicators.
- No pregnant or breastfeeding women, and a negative pregnancy test.
- Understood and signed an informed consent form.
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Squamous cell carcinoma meets following conditions should be excluded:
- Cavernous lung cancer.
- Has hemoptysis and maximum daily hemoptysis volume ≥ 2.5ml within 1 month before the first administration.
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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.
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Severe hypersensitivity occurs after administration of other monoclonal antibodies.
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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.
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Pathologically confirmed mixed small cell and non-small cell lung cancer.
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EGFR gene mutations.
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Has any active autoimmune disease or history of autoimmune disease.
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After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.
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Has ≥grade 2 pneumonia.
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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.
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Has multiple factors affecting oral medication.
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Has active bleeding or a persistent decrease in hemoglobin.
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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.
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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.
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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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQB2450+Anlotinib TQB2450 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) TQB2450 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+Anlotinib(blank) 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). TQB2450(blank)+Anlotinib(blank) TQB2450(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). TQB2450(blank)+Anlotinib(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). TQB2450+Anlotinib 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).
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC) 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
Name Time Method Overall survival (OS) 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.
PFS evaluated by Investigator 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.
Disease control rate（DCR） up to 33 months Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of response（DOR） up to 33 months The time when the participants first achieved complete or partial remission to disease progression.
Biomarkers, such as PD-L1 expression, etc. 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).
PFS rate at month 6 up to 6 months The percentage of PFS at month 6
PFS rate at month 12 up to 12 months The percentage of PFS at month 12
Immunogenicity, such as the incidence of ADA on day 1, 42, 105, 189 and 90 days after the last administration. Degree of the immune response caused by the drug.
Overall response rate (ORR) up to 33 months Percentage of participants achieving complete response (CR) and partial response (PR).
Trial Locations
- Locations (36)
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, 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
Yuebei People's Hospital
🇨🇳Shaoguan, Guangdong, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhangjiang, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
🇨🇳Zhuhai, Guangdong, China
Scroll for more (26 remaining)Anhui Chest Hospital🇨🇳Hefei, Anhui, ChinaXuhong MinPrincipal Investigator