The Predicted Potential of Quantitative T Cell Repertoire(TCR) in Anti-PD-L1 Treatment in NSCLC Patients

The Predicted Potential of Quantitative T Cell Repertoire(TCR) Analysis Using Next-generation Sequencing (NGS) in Anti-PD-L1 Treatment in Non Small Cell Lung(NSCLC) Cancer Patients

This study is designed to evaluate the predicted potential of quantitative T cell repertoire (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression or unacceptable toxicity.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: The First Affiliated Hospital of College of Medicine, Zhejiang

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed during or following treatment with a prior platinum-containing regimen and subsequently recevied atezolizumab.

Description

Inclusion Criteria:

  • Histologically documented, locally advanced or metastatic NSCLC
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
  • Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, or disease recurrence within 6 months of treatment with a platinum-based adjuvant and/or neoadjuvant regimen or combined modality with curative intent
  • Measurable disease per RECIST Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematologic and end organ function
  • Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
  • Recovery from all acute toxicities from previous therapy

Exclusion Criteria:

  • Active or untreated central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated or not clinically stable
  • Leptomeningeal disease
  • Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  • Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
  • Pregnant or lactating women
  • Significant cardiovascular, pulmonary, or autoimmune disease
  • Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
  • Prior treatment with or hypersensitivity to study drug(s) or related compounds
  • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
  • Prior allogeneic bone marrow or solid organ transplant
  • Known PD-L1 expression status from other clinical studies
  • Positive human immunodeficiency virus (HIV) or hepatitis B or C
  • Receipt of a live attenuated vaccine within 4 weeks prior to randomization
  • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids within 2 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atezolizumab (MPDL3280)
Atezolizumab 1200 milligrams (mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
anti-programmed death-ligand 1 (PD-L1) antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell repertoire
Time Frame: From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)
Change of T cell receptor repertoire during Anti-PL-L1 treatment.
From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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