Small Cell Lung Cancer, Polygonal TypeATHENENCT03029858
PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients
An observational study of Small Cell Lung Cancer, Polygonal Type, run by Guangdong Association of Clinical Trials at 12 sites in China.
Trial summary
The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Polygonal Type
- How many people
- 155 participants
- Where
- 12 sitesChina
- Study dates
- Jan 2017to Sep 2020
- 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: Adult patients (≥18 years old) with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC with confirmed T790M mutation, who have received prior EGFR-TKI therapy，These patients are those who were enrolled in ASTRIS（Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC） or patients who were eligible for the ASTRIS study. The study is a post observational study for ASTRIS study，and the patients would not take Osimertinib in this study any more.
Who may be able to join
- The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
- The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
- Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
- Fine needle aspirate specimens are not acceptable.
- Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
- The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks.
Who cannot join
- The patient does not have sufficient tumor tissue specimen available for detection.
- The Patient who is unwilling to use the existing data from medical practice for scientific research.
- The patient who received immunotherapy therapy before.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Fujian Medical University Union Hospital
Fuzhou, Fujian
Fujian Principal Cancer Hospital
Fuzhou, Fujian
The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.
Hangzhou, Zhejiang
The first Affiliated hospital of Zhejiang University，Respiratory dept.
Hangzhou, Zhejiang
The second Affiliated hospital of Zhejiang University of Medicine
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The second affiliated hospital of Nanchang University
Nanchang, Jiangxi
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jianhua Chang
Shanghai Chest Hospital Oncology dept.
Shanghai, Shanghai Municipality
Shun Lu, +86 13601813062, shun_lu@hotmail.com
Shanghai Chest Hospital Respiratory dept.
Shanghai, Shanghai Municipality
Liyan Jiang
Zhejiang Taizhou Hospital
Taizhou, Zhejiang
About this study
Official title: Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
Read the detailed description
Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
- Conditions
- Small Cell Lung Cancer, Polygonal Type
- Being tested
- No interventions will be taken in this Observational study
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions will be taken in this Observational studyOther
TAGRISSO(osimertinib/AZD9291）
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure PD-L1 value
Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）
Measured: baseline and PD，up to 24 months
Measure PD-L1 expression positive rate (%)
Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）
Measured: baseline and PD，up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer, Polygonal TypeStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shun Lu, M.D, Principal investigator, Shanghai Chest hospital of Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029858
- Sponsor's protocol ID
- CTONG1605
- Other IDs
- ESR-16-12177
- Acronym
- ATHENE
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
- ClinicalTrials.gov ID
- NCT03029858
- Acronym / sponsor ID
- ATHENE / CTONG1605
- Conditions
- Small Cell Lung Cancer, Polygonal Type
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
Detailed description
Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC with confirmed T790M mutation, who have received prior EGFR-TKI therapy，These patients are those who were enrolled in ASTRIS（Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC） or patients who were eligible for the ASTRIS study. The study is a post observational study for ASTRIS study，and the patients would not take Osimertinib in this study any more.
Key inclusion criteria (6 listed)
- The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
- The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
- Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
- Fine needle aspirate specimens are not acceptable.
- Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
Key exclusion criteria (3 listed)
- The patient does not have sufficient tumor tissue specimen available for detection.
- The Patient who is unwilling to use the existing data from medical practice for scientific research.
- The patient who received immunotherapy therapy before.
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 |
|---|---|---|
| No interventions will be taken in this Observational studyTAGRISSO(osimertinib/AZD9291） | Other | – |
Primary outcome
Measure PD-L1 value
Time frame: baseline and PD，up to 24 months
Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）
Measure PD-L1 expression positive rate (%)
Time frame: baseline and PD，up to 24 months
Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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.
Shun Lu, M.D principal investigator
Shanghai Chest hospital of Shanghai Jiaotong University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, Polygonal Type, run by Guangdong Association of Clinical Trials at 12 sites 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 6 inclusion and 3 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 Shun Lu, M.D (86-13601813062, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure PD-L1 value (time frame: baseline and PD，up to 24 months). The study lists 2 primary outcomes in all. 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 Jan 2017.