Stage III Non-small-cell Lung Cancer
Conditions
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.
Interventions
DRUGTQB2450
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
DRUGAnlotinib
a multi-target receptor tyrosine kinase inhibitor
DRUGTQB2450(blank)
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
DRUGAnlotinib(blank)
Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Overall response rate (ORR) | up to 33 months | Percentage of participants achieving complete response (CR) and partial response (PR). |
| 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. |
| 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. |
| PFS rate at month 12 | up to 12 months | The percentage of PFS at month 12 |
| 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). |
| 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. |
| PFS rate at month 6 | up to 6 months | The percentage of PFS at month 6 |
Countries
China
Contacts
Primary ContactMing Chen
Outcome results
None listed