NCT04059887

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

August 9, 2019

Last Update Submit

February 6, 2023

Conditions

Lung Neoplasm Malignant

Keywords

Non-small cell lung cancerImmune checkpoint inhibitorTumor mutation burden

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    ORR between blood TMB-High vs. Low group

    At the end of cycle 3 (each cycle is 21 days)

Secondary Outcomes (2)

  • Progression-free survival (PFS)

    At the end of cycle 3 (each cycle is 21 days)

  • Safety profile

    Through study completion, an average of 1 year

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Atezolizumab 1200 mg will be administrated every 3 week cycle

Drug: Atezolizumab Injection [Tecentriq]

Interventions

Atezolizumab Injection [Tecentriq]DRUG

Blood sampling will be performed before and after 3rd cycle of atezolizumab for evaluation of tumor mutation burden

Also known as: Tecentriq
Atezolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form
  • Ability to comply with protocol
  • Aged ≥ 18 years
  • 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
  • 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.
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Life expectancy ≥ 12 weeks
  • 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.
  • +2 more criteria

You may not qualify if:

  • Active or untreated central nervous system (CNS) metastases Patients with a history of treated CNS metastases that are asymptomatic are eligible
  • 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)
  • 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.
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study enrollment
  • 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.
  • Uncontrolled idiopathic pulmonary fibrosis or drug-induced pneumonitis
  • 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.
  • Patient with a known hypersensitivity to atezolizumab or any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Related Publications (2)

  • Kim ST, Cristescu R, Bass AJ, Kim KM, Odegaard JI, Kim K, Liu XQ, Sher X, Jung H, Lee M, Lee S, Park SH, Park JO, Park YS, Lim HY, Lee H, Choi M, Talasaz A, Kang PS, Cheng J, Loboda A, Lee J, Kang WK. Comprehensive molecular characterization of clinical responses to PD-1 inhibition in metastatic gastric cancer. Nat Med. 2018 Sep;24(9):1449-1458. doi: 10.1038/s41591-018-0101-z. Epub 2018 Jul 16.

    PMID: 30013197RESULT

  • Gandara DR, Paul SM, Kowanetz M, Schleifman E, Zou W, Li Y, Rittmeyer A, Fehrenbacher L, Otto G, Malboeuf C, Lieber DS, Lipson D, Silterra J, Amler L, Riehl T, Cummings CA, Hegde PS, Sandler A, Ballinger M, Fabrizio D, Mok T, Shames DS. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med. 2018 Sep;24(9):1441-1448. doi: 10.1038/s41591-018-0134-3. Epub 2018 Aug 6.

    PMID: 30082870RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • In-Jae Oh, MD, PhD

    Chonnam National Univeristy Hwasun Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 16, 2019

Study Start

December 18, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)