Non-Small Cell Lung CancerNCT03228368
The Predicted Potential of Quantitative T Cell Repertoire(TCR) in Anti-PD-L1 Treatment in NSCLC Patients
An observational study of Non-Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Atezolizumab (MPDL3280A)
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Director of Department of Thoracic Oncology contact
The First Affiliated Hospital of College of Medicine, Zhejiang contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Wei Chen, cli6274@gmail.com
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Atezolizumab (MPDL3280A)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab (MPDL3280A)Drug
anti-programmed death-ligand 1 (PD-L1) antibody
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Atezolizumab (MPDL3280A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell repertoire
Change of T cell receptor repertoire during Anti-PL-L1 treatment.
Measured: From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Geneplus-Beijing Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228368
- Sponsor's protocol ID
- TCR-1
- Status last verified
- Mar 2017
- First submitted
- 28 Jun 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03228368
- Acronym / sponsor ID
- TCR-1
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Geneplus-Beijing Co. Ltd.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab (MPDL3280) | – | Drug: Atezolizumab (MPDL3280A)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab (MPDL3280A)anti-programmed death-ligand 1 (PD-L1) antibody | Drug | Atezolizumab (MPDL3280) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director of Department of Thoracic Oncology contact
The First Affiliated Hospital of College of Medicine, Zhejiang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director of Department of Thoracic Oncology (doczq.2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell repertoire (time frame: From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.