Status:
UNKNOWN
A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC)
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Stage III Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 compa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- Severe hypersensitivity occurs after administration of other monoclonal antibodies.
- 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.
- Pathologically confirmed mixed small cell and non-small cell lung cancer.
- EGFR gene mutations.
- Has any active autoimmune disease or history of autoimmune disease.
- After the early stage of chemoradiotherapy, the treatment toxicity ≥ grade 2 is not fully alleviated.
- Has ≥grade 2 pneumonia.
- 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.
- Has multiple factors affecting oral medication.
- Has active bleeding or a persistent decrease in hemoglobin.
- Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration.
- 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.
- 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.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04325763
Start Date
May 27 2020
End Date
March 1 2025
Last Update
March 31 2022
Active Locations (36)
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1
Anhui Chest Hospital
Hefei, Anhui, China, 230000
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000