Clinical trial NCT04325763: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stage III Non-small-cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \&gt; 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.

Primary outcomes:
measure: Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
timeFrame: up to 33 months
Secondary outcomes:
measure: PFS evaluated by Investigator
timeFrame: up to 33 months
measure: Overall survival (OS)
timeFrame: up to 5 years
measure: Overall response rate (ORR)
timeFrame: up to 33 months
measure: Disease control rate（DCR）
timeFrame: up to 33 months
measure: Duration of response（DOR）
timeFrame: up to 33 months
measure: PFS rate at month 6
timeFrame: up to 6 months
measure: PFS rate at month 12
timeFrame: up to 12 months
measure: Biomarkers, such as PD-L1 expression, etc.
timeFrame: up to 33 months
measure: Immunogenicity, such as the incidence of ADA
timeFrame: on day 1, 42, 105, 189 and 90 days after the last administration.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Chest Hospital
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital Sun Yat-Sen University
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Zhangjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-Sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei medical University
state: Hebei
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Huai'an
country: China
facility: Huaian First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xijing Hospital of Airforce Medical University
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'anjiantong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The first Hospital of Zhengjiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
References: