Carcinoma, Non-Small-Cell LungPEMBREIZHNCT05321212
Efficacy and Safety of PEMbrolizumab PD-L1-positive (>50% of Tumor Cells), Advanced NSCL Cancer(PEMBREIZH)
An observational study of Carcinoma, Non-Small-Cell Lung and Immunotherapy, run by University Hospital, Brest at 2 sites in France.
Trial summary
This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2019to 2 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-small-cell lung cancer with PDL1 TPS > 50% treated in first line with pembrolizumab
Who may be able to join
- histologically or cytologically confirmed NSCLC PD- L1 TPS ≥ 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function
Who cannot join
- previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Efficacy (Systemic and Cerebral) and Safety of PEMbrolizumab PD-L1-positive (More Than 50% of Tumor Cells), Advanced Non-small-cell Lung Cancer : A Study of Real Life in Brittany .
This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- Keywords
- pembrolizumab, first line treatment, PDL1 TPS > 50%, brain efficacy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival with pembrolizumab
time from initiation of pembrolizumab to the date of disease progression or death
Measured: time from initiation of pembrolizumab to the date of disease progression or death ( 20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 Jan 2019
- Primary completion2 Jan 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321212
- Sponsor's protocol ID
- PEMBREIZH (29BRC18.0260)
- Acronym
- PEMBREIZH
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy (Systemic and Cerebral) and Safety of PEMbrolizumab PD-L1-positive (More Than 50% of Tumor Cells), Advanced Non-small-cell Lung Cancer : A Study of Real Life in Brittany .
- ClinicalTrials.gov ID
- NCT05321212
- Acronym / sponsor ID
- PEMBREIZH / PEMBREIZH (29BRC18.0260)
- Conditions
- Carcinoma, Non-Small-Cell Lung, Immunotherapy
- Keywords
- pembrolizumab, first line treatment, PDL1 TPS > 50%, brain efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 11 Apr 2022 (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 was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small-cell lung cancer with PDL1 TPS > 50% treated in first line with pembrolizumab
Key inclusion criteria (1 listed)
- histologically or cytologically confirmed NSCLC PD- L1 TPS ≥ 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function
Key exclusion criteria (1 listed)
- previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression free survival with pembrolizumab
Time frame: time from initiation of pembrolizumab to the date of disease progression or death ( 20 months)
time from initiation of pembrolizumab to the date of disease progression or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Immunotherapy, run by University Hospital, Brest at 2 sites in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival with pembrolizumab (time frame: time from initiation of pembrolizumab to the date of disease progression or death ( 20 months)). 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 11 Apr 2022.