A Phase 3 interventional study of Consolidation Sintilimab in Carcinoma, Non-Small Cell Lung, sponsored by Shandong Cancer Hospital and Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Shandong Cancer Hospital and Institute · Phase 3, Interventional, and Treatment
This is an open label, multi-center, randomized, control phase III trial, to compare the efficacy and safety of consolidation therapy with sintilimab (IBI308) versus best supported care (BSC), in unresectable stage III NSCLC patients who do not experience disease progression after initial concurrent chemoradiation.
This is an open label, multi-center, randomized, control study of sintilimab versus BSC in unresectable local advanced stage III NSCLC patients without disease progression after concurrent chemoradiation.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 162 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Previous immune therapy including: anti PD-1, anti PD-L1, anti PD-L2 or treatment targeting other co-stimulatory or co-inhibitory T-cell receptors [e.g. cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, and CD137]
a) Systemic therapy with Chinese patent medicine or drugs of immunoregulation effect (including thymosin, interferon, interleukin, unless local delivery for controlling pleural effusion) within 2 weeks prior to the first dose of study treatment, or major surgery within 4 weeks prior to the first dose of study treatment
A history of active autoimmune disease requiring systemic treatment (e.g. using drugs for disease remission, corticosteroids or immunosuppressor) within 2 years prior to the first dose of study treatment. Substitution therapy (e.g. thyroxine, insulin or physiological corticosteroids for treating adrenal or pituitary dysfunction) is not considered as a systemic treatment.
a) Diagnosis as immunodeficiency, or being treated with systemic glucocorticoid or other kinds of immunosuppressor within 7 days prior to the first dose of study treatment. A physiological dose of glucocorticoid (≤10 mg/day prednisone or equivalent dose of other steroids) is permitted.
Untreated active viral hepatitis B (HBV)
Patients with HBV who meet the following criteria are also eligible:
Sintilimab consolidation therapy
Drug: Consolidation Sintilimab
Observation
Sintilimab consolidation therapy after concurrent chemoradiation, 200mg IV, every 3 weeks, until progressive disease (PD, unless patients can continuously benefit from study treatment per investigators' judgement), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Sintilimab will be given at a maximum of 12 months.
Progression Free Survival (PFS)
PFS (per RECIST 1.1 as assessed by the investigator) will be defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression).
Time frame: up to 24 months after enrollment or study close
Overall survival (OS)
OS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomisation until death due to any cause.
Time frame: up to 24 months after enrollment or study close
Objective Response Rate (ORR)
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Time frame: up to 24 months after enrollment or study close
Disease Control Rate (DCR)
DCR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).
Time frame: up to 24 months after enrollment or study close
Duration of Response (DoR)
DoR (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) until the date for the first documented response of progressive disease (PD) or death in the absence of progression.
Time frame: up to 24 months after enrollment or study close
Progression Free Survival (PFS) Rate at 12/18 months
PFS rate at 12/18 months is defined as the proportion (%) of patients who are alive and progression free at 12 and 18months from the date of randomisation.
Time frame: From the date of randomization until the Kaplan-Meier estimate of PFS at 12/18months
Treatment-related Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.03 from the date of randomization to 90 days after last dose of study treatment.
Time frame: From the date of randomization to 90 days after last dose of study treatment
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shandong Cancer Hospital and Institute