Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    162
  • sponsor
    Shandong Cancer Hospital and Institute
Updated on 23 January 2021

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.

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment Consolidation Sintilimab
Clinical Study IdentifierNCT03884192
SponsorShandong Cancer Hospital and Institute
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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]
Adequate liver function, defined as: total serum bilirubin 1.5 x upper limit of normal (ULN); serum alanine transaminase (ALT) and aspartic transaminase (AST) 2.5 x ULN, with no liver transplantation
Adequate renal function, defined as: serum creatinine 1.5 x ULN or calculated creatinine-clearance 60 ml/min (Cockcroft-Gault). Urine protein less than 2+ by urinalysis or 24-hour urinary protein quantity < 1g
Adequate coagulation function, defined as: international normalized ratio (INR) or prothrombin time (PT) 1.5 x ULN. For patients receiving anticoagulant therapy can be enrolled if PT is within the range defined by anticoagulant therapy
Myocardial enzymes are within normal range
All subjects of childbearing potential must agree to use efficient contraceptive methods that result in a failure rate of < 1% per year during the study treatment period and for at least 180 days after discontinuation from study treatment

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]
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
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
Previously diagnosis as other malignant tumors within 5 years prior to the first dose of study treatment, with the exception of: skin basal cell carcinoma or squamous cell carcinoma with radical treatment, and/or carcinoma in situ underwent radical resection
History of non-infectious pneumonitis requiring treatment with glucocorticoid within 1 year prior to the first dose of study treatment, or currently existed interstitial lung disease
Active infectious that required systemic therapy
Know psychiatric illness or drug abuse that would limit compliance with study requirements
Know human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive)
Untreated active viral hepatitis B (HBV)
Patients with HBV who meet the following criteria are also eligible
HBV virus load (VL) <1000 copy/ml (200 IU/ml), and patients must continuously receive anti-HBV therapy during all through study treatment phase to prevent virus activation
Patients with a result of anti-HBc(+)HBsAg (-)anti-HBs (-) HBV VL (-) are not required to receive prophylactic anti-HBV therapy, but must be closely monitored for virus re-activation
Patients with active HCV infection (HCV antibody positive and HCV-RNA > the lower detection limit)
History or evidence of disease, treatment or laboratory abnormalities that would interfere the study outcome, prevent patients from participating entirely, or ineligible to enroll per the investigators' judgement
Pregnant or lactating women
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