Description:
This is single arm, prospective, multi-center, cohort study to evaluate blood TMB for
improved efficacy of atezolizumab in locally advanced or metastatic NSCLC at the study
enrollment who failed one or more prior lines of chemotherapy including at least 1
platinum-based.
Title
- Brief Title: Evaluation of Blood TMB for the Efficacy of Atezolizumab [BUDDY]
- Official Title: Evaluation of Blood Tumor Mutation Burden (TMB) for Improved Efficacy of Atezolizumab in 2nd Line Non-small Cell Lung Cancer (NSCLC) [BUDDY]
Clinical Trial IDs
- ORG STUDY ID:
H2019-0351
- NCT ID:
NCT04059887
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Atezolizumab Injection [Tecentriq] | Tecentriq | Atezolizumab |
Purpose
This is single arm, prospective, multi-center, cohort study to evaluate blood TMB for
improved efficacy of atezolizumab in locally advanced or metastatic NSCLC at the study
enrollment who failed one or more prior lines of chemotherapy including at least 1
platinum-based.
Detailed Description
Atezolizumab is approved as the treatment of patients with locally advanced or metastatic
NSCLC who have disease progression during or following platinum-containing chemotherapy by
the Ministry of Food and Drug Safety (MFDS) and the treatment is available on the National
Health Insurance Service in South Korea. Patients will be treated with atezolizumab until
loss of clinical benefit or unmanageable toxicity as routine practice.
In this study, the investigators will register patients who have a plan to be treated with
atezolizumab as MFDS approval condition and meet study inclusion and exclusion criteria. The
investigators will collect study related information during routine practice and collect
blood and/or tissue(optional) samples to conduct the study.
Tumor assessment will be performed by investigator on the base of RECIST (version 1.1) and
related information will be collected until disease progression for patients who have
discontinued treatment. However, it will be collected until treatment discontinuation for
patients who continue to receive atezolizumab following initial disease progression.
Trial Arms
Name | Type | Description | Interventions |
---|
Atezolizumab | Experimental | Atezolizumab 1200 mg will be administrated every 3 week cycle | - Atezolizumab Injection [Tecentriq]
|
Eligibility Criteria
Inclusion Criteria:
1. Signed Informed Consent Form
2. Ability to comply with protocol
3. Aged ≥ 18 years
4. Histologically or cytologically confirmed NSCLC that is locally advanced or metastatic
(i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or
recurrent) NSCLC at the study enrollment
5. Disease progression during or following treatment with a prior platinum-containing
regimen for NSCLC
- Patients may have received one or more additional cytotoxic chemotherapy regimen.
- Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) genomic tumor aberrations should have disease progression on
approved therapy for these aberrations prior to receiving atezolizumab.
6. Measurable disease, as defined by RECIST v1.1 Measurable disease is defined by the
presence of at least one measurable lesion by RECIST v1.1
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
8. Life expectancy ≥ 12 weeks
9. Adequate hematologic and end organ function:
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
- White blood cell (WBC) counts > 2.5 x 109/L
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 2.5 X upper limit of normal (ULN) Patients with known Gilbert's
disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
- Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline
phosphatase ≤ 2.5 × ULN, with the following exceptions:
Patients with documented liver metastases: AST and ALT ≤ 5 × ULN Patients with documented
liver or bone metastases: alkaline phosphatase ≤ 5 × ULN
Exclusion Criteria:
1. Active or untreated central nervous system (CNS) metastases Patients with a history of
treated CNS metastases that are asymptomatic are eligible
2. Malignancies other than NSCLC within 5 years prior to study enrollment, with the
exception of those with a negligible risk of metastasis or death and treated with
expected curative outcome (such as adequately treated carcinoma in situ of the cervix,
basal or squamous cell skin cancer, localized prostate cancer treated with curative
intent, or ductal carcinoma in situ treated surgically with curative intent)
3. Pregnant and lactating women
• Women of childbearing potential should use effective contraception during treatment
with atezolizumab and for at least 5 months following the last dose.
4. Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction within 3 months prior to study enrollment
5. Patients with autoimmune disorder or a history of chronic or recurrent autoimmune
disorder
- Patients with a history of autoimmune-mediated hypothyroidism on a stable dose of
thyroid replacement hormone may be eligible for this study.
- Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may
be eligible for this study.
6. Uncontrolled idiopathic pulmonary fibrosis or drug-induced pneumonitis
7. Treatment with systemic corticosteroids or other systemic immunosuppressive
medications (including prednisone, dexamethasone, cyclophosphamide, azathioprine,
methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior
to study enrollment
• Treatment with inhaled corticosteroid or megesterol acetate is permitted.
8. Patient with a known hypersensitivity to atezolizumab or any of the excipients
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) |
Time Frame: | At the end of cycle 3 (each cycle is 21 days) |
Safety Issue: | |
Description: | ORR between blood TMB-High vs. Low group |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | At the end of cycle 3 (each cycle is 21 days) |
Safety Issue: | |
Description: | PFS in Intention-to-treat (ITT) population and subgroups according to blood TMB and programmed cell death-1 (PDL1) status |
Measure: | Safety profile |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Incidence of Treatment-related Adverse Events as assessed by CTCAE version 4 |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Chonnam National University Hospital |
Trial Keywords
- Non-small cell lung cancer
- Immune checkpoint inhibitor
- Tumor mutation burden
Last Updated
January 27, 2021