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

NCT03228368 | Unknown FDA Drug

• 1 other identifier: TCR-1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• T cell repertoire

  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)

Study Arms (1)

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.

Drug: Atezolizumab (MPDL3280A)

Interventions

Atezolizumab (MPDL3280A) DRUG

anti-programmed death-ligand 1 (PD-L1) antibody

Atezolizumab (MPDL3280)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Hoffmann-La Roche: collaborator
• Geneplus-Beijing Co. Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Director of Department of Thoracic Oncology

CONTACT

doczq.2008@163.com

The First Affiliated Hospital of College of Medicine, Zhejiang

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 24, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 24, 2017

Record last verified: 2017-03

Locations

CN (1)