CONSIST: A Phase III Randomized Control Study of Consolidation Sintilimab (IBI308) After Concurrent Chemoradiation Versus Chemoradiation Alone in Patients With Unresectable Local Advanced Stage III NSCLC

Shandong Cancer Hospital and Institute1 site in 1 country162 target enrollmentDecember 12, 2018

ConditionsCarcinoma, Non-Small Cell Lung

InterventionsConsolidation Sintilimab

DrugsConsolidation Sintilimab

Overview

Phase: Phase 3
Intervention: Consolidation Sintilimab
Conditions: Carcinoma, Non-Small Cell Lung
Sponsor: Shandong Cancer Hospital and Institute
Enrollment: 162
Locations: 1
Primary Endpoint: Progression Free Survival (PFS)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 12, 2018

End Date

December 30, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Cancer Hospital and Institute

Responsible Party

Principal Investigator

Jinming Yu

President of Shandong Cancer Hospital and Institute

Shandong Cancer Hospital and Institute

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent before initiation of any study procedures
•Age ≥ 18 years and ≤ 75 years
•Histologically or cytologically confirmed NSCLC, with unresectable local advanced disease (stage III according to NSCLC staging version 8)
•Expected survival over 3 months
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•At least 1 measurable disease according to RECIST 1.1
•Pulmonary function: forced expiratory volume at one second (FEV1) \> 1 liter(L)
•Patient must not have received any anti-cancer therapy for the purpose of treating lung cancer. However, exploratory thoracotomy, mediastinoscopy, excision biopsy, and other kinds of surgery for diagnosis and staging purpose is acceptable. Patients with local or regional recurrent disease after pneumonectomy is allowed to participate if they meet other inclusion criteria (e.g. stage III, inappropriate for re-operation).
•For all female patients of childbearing potential, a negative pregnancy test (either urine or serum) must be obtained within 3 days before the first dose (Cycle 1, Day 1) of study treatment. If a urine pregnancy test shows an unconfirmed result, a serum pregnancy test must be performed.
•Adequate hematopoietic function, defined as: absolute neutrophil count (ANC) ≥ 1.5 x 10\*9/L; platelet count ≥100 x 10\*9/L; hemoglobin ≥90 g/L \[no blood transfusion within 7 days or not erythropoietin (EPO) dependent\]

Exclusion Criteria

•Being treated by other investigational drugs within an interventional study, or have received any investigational drugs or instruments within 4 weeks prior to the first dose of study treatment
•Being enrolled in other interventional studies, unless they are observational studies or during the follow-up stage of an interventional study
•NSCLC histology with small cell lung cancer (SCLC) components
•Active or autoimmune disease history (within the past 2 years), or history of immune deficiency
•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
•Clinical evidence of active diverticulitis, abdominal abscess, or gastrointestinal obstruction
•Previous organ or blood system transplantation
•Known allergic to pemetrexed, paclitaxel, etoposide, cisplatin, carboplatin, sintilimab component and/or any excipients
•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.

Arms & Interventions

Sintilimab Arm

Sintilimab consolidation therapy

Intervention: Consolidation Sintilimab

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: up to 24 months after enrollment or study close

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).

Secondary Outcomes

Overall survival (OS)(up to 24 months after enrollment or study close)
Objective Response Rate (ORR)(up to 24 months after enrollment or study close)
Disease Control Rate (DCR)(up to 24 months after enrollment or study close)
Duration of Response (DoR)(up to 24 months after enrollment or study close)
Progression Free Survival (PFS) Rate at 12/18 months(From the date of randomization until the Kaplan-Meier estimate of PFS at 12/18months)
Treatment-related Adverse Events (AEs)(From the date of randomization to 90 days after last dose of study treatment)