Non Small Cell Lung CancerT-STARNCT02368990
T790M Mutation Positive 2nd Line STandard of cAre Registry
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 49 sites in 9 countries.
Trial summary
The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 0 participants
- Where
- 49 sitesin 9 countries
- Study dates
- Jun 2015to Jun 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 with confirmed EGFRm+, T790M mutation positive, locally advanced or metastatic NSCLC who have been prescribed pemetrexed + cisplatin/carboplatin in accordance with clinical practice after 1st line treatment with approved EGFR-targeted TKI will be selected from approximately 100 sites across 17 countries worldwide.
Who may be able to join
- Provision of signed and dated written informed consent prior to any study specific procedure.
- Patients with histologically- or cytologically-documented NSCLC who present with Stage IIIB/ Stage IV disease.
- Evidence of radiological disease progression following 1st line treatment for advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting is permitted.
- Patients prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. Patient must be enrolled into the study within two cycles of beginning treatment. Treatment must be given in accordance with local prescribing information.
- Confirmation prior to enrolment into the study that the tumour harbours the following EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del, L858R, L861Q, and G719X.
- Patients must have had confirmation that tumour is T790M mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved EGFR-targeted TKI.
- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Who cannot join
- Treatment with any of the following:
- Prior treatment with more than one line of treatment for advanced NSCLC.
- Major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
- Palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to enrolment.
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
- Patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. However, inclusion in this study does not preclude participation in any other clinical study after enrolment. Patients who participate in clinical studies after enrolment into this study will be followed to the extent possible as permitted by the sponsor of that clinical study.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the site).
- Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
Spain13 sites
Research Site
A Coruña
Research Site
Alicante
Research Site
Badalona
Research Site
Barcelona
Research Site
León
Research Site
Lugo
Research Site
Madrid
Research Site
Ourense
Research Site
Pamplona
Research Site
Santander
Research Site
Seville
Research Site
Valencia
Research Site
Vizcaya
Italy10 sites
Research Site
Catania
Research Site
Ferrara
Research Site
Messina
Research Site
Modena
Research Site
Naples
Research Site
Padova
Research Site
Parma
Research Site
Perugia
Research Site
Rome
Research Site
Torino
China9 sites
Research Site
Beijing
Research Site
Changsha
Research Site
Guangzhou
Research Site
Jiangsu
Research Site
Jilin City
Research Site
Shanghai
Research Site
Shanghai Ruijin Hospital
Research Site
Sichuan Cancer Hospital
Research Site
Xi'an
France7 sites
Research Site
Boulogne-Billancourt
Research Site
Bretagne
Research Site
La Chaussée-Saint-Victor
Research Site
Lille
Research Site
Pontoise
Research Site
Rhone-Alpes
Research Site
Saint-Quentin
United States3 sites
Research Site
Kentucky, Kentucky
Research Site
Langhorne, Pennsylvania
Research Site
Maryland City, Maryland
Taiwan3 sites
Research Site
Linkou District
Research Site
Taichung
Research Site
Taipei
About this study
Official title: T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
Read the detailed description
The study is an observational prospective cohort study that plans to enroll approximately 200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X). Further tests on biopsied tissue or cytology at progression after treatment with an approved EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of the study are :
- To estimate overall survival
- To estimate disease progression (as assessed and defined by physician)
- To estimate time on treatment by line of therapy
- To describe time to subsequent therapies (or death)
- To describe healthcare resource utilization patterns
- To capture patient reported symptoms, functioning, and health-related quality of life (HRQoL) data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
- To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment
- To describe treatment patterns for 3rd line treatment and beyond
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, T790M, EGFR, TKI Resistance, Non Small Cell Lung Cancer, AZD9291, Clovis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC T790M positive | NSCLC patients who have had 1st line treatment with an approved EGFR targeted TKI, who are known to be T790M mutation positive and who have been prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) as a 2nd line treatment as part of their standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause or censoring (at end of 24 months).To assess efficacy of permetrexed + cisplatinum/carboplatin as the 2nd line of treatment of NSCLC.
Measured: 24 months from last subject in
Secondary outcomes (7)
Response to Therapy as assessed by the physician
This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death (by any cause in the absence of progression). To assess efficacy of 2nd line treatment and beyond.
Measured: 24 months from last subject in
Time on treatment by line of therapy and between therapies
This will be assessed as the time from start date of line of therapy to end date of line of therapy or death date. To describe treatment patterns for 2nd line and beyond.
Measured: 24 months from last subject in
Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
This will be assessed as the number and Time from the dates of admission and exit of attendance. To describe Healthcare resource utilization for 2nd line treatment and beyond.
Measured: 24 months from last subject in
Time to symptom deterioration
For each of the symptoms in EORTC QLQ-LC13 and EORTC QLQ-C30, Time from inclusion until the date of first clinically meaningful symptom deterioration or death by any cause in the absence of a clinically meaningful symptom deterioration. To assess the impact of 2nd and subsequent lines of therapy on patients' disease-related symptoms and health related quality of life.
Measured: 24 months from last subject in
Symptom Improvement Rate
This will be assessed as the number of patients with two consecutive assessments, which showed a clinically meaningful improvement in that symptom from baseline. To assess the impact of 2nd and subsequent lines of therapies on patients' disease-related symptoms and health related quality of life.
Measured: 24 months from last subject in
Duration of Response as defined by the physician
This will be assessed as the time from the date of complete or partial response until the first date of recurrence or progression. To assess the efficacy of 2nd line treatment and beyond.
Measured: 24 months from last subject in
Progression Free Survival
This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death by any cause. This will be done to assess efficacy of pemetrexed + cisplatin/carboplatin as the 2nd line treatment of NSCLC.
Measured: 24 months from last subject in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Since the conception of the study, the competitive environment has developed and as a result this study is no longer able to generate the necessary information.
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 AstraZenecaThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368990
- Sponsor's protocol ID
- D5160R00001
- Acronym
- T-STAR
- Status last verified
- Jul 2015
- First submitted
- 29 Jan 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
- ClinicalTrials.gov ID
- NCT02368990
- Acronym / sponsor ID
- T-STAR / D5160R00001
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, T790M, EGFR, TKI Resistance, Non Small Cell Lung Cancer, AZD9291, Clovis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Since the conception of the study, the competitive environment has developed and as a result this study is no longer able to generate the necessary information.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 23 Feb 2015 (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 aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
Detailed description
The study is an observational prospective cohort study that plans to enroll approximately 200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X). Further tests on biopsied tissue or cytology at progression after treatment with an approved EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of the study are :
- To estimate overall survival
- To estimate disease progression (as assessed and defined by physician)
- To estimate time on treatment by line of therapy
- To describe time to subsequent therapies (or death)
- To describe healthcare resource utilization patterns
- To capture patient reported symptoms, functioning, and health-related quality of life (HRQoL) data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
- To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment
- To describe treatment patterns for 3rd line treatment and beyond
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC T790M positive | – | –NSCLC patients who have had 1st line treatment with an approved EGFR targeted TKI, who are known to be T790M mutation positive and who have been prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) as a 2nd line treatment as part of their standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed EGFRm+, T790M mutation positive, locally advanced or metastatic NSCLC who have been prescribed pemetrexed + cisplatin/carboplatin in accordance with clinical practice after 1st line treatment with approved EGFR-targeted TKI will be selected from approximately 100 sites across 17 countries worldwide.
Key inclusion criteria (7 listed)
- Provision of signed and dated written informed consent prior to any study specific procedure.
- Patients with histologically- or cytologically-documented NSCLC who present with Stage IIIB/ Stage IV disease.
- Evidence of radiological disease progression following 1st line treatment for advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting is permitted.
- Patients prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. Patient must be enrolled into the study within two cycles of beginning treatment. Treatment must be given in accordance with local prescribing information.
- Confirmation prior to enrolment into the study that the tumour harbours the following EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del, L858R, L861Q, and G719X.
Key exclusion criteria (8 listed)
- Treatment with any of the following:
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
- Patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. However, inclusion in this study does not preclude participation in any other clinical study after enrolment. Patients who participate in clinical studies after enrolment into this study will be followed to the extent possible as permitted by the sponsor of that clinical study.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the site).
- Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
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
Overall Survival
Time frame: 24 months from last subject in
This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause or censoring (at end of 24 months).To assess efficacy of permetrexed + cisplatinum/carboplatin as the 2nd line of treatment of NSCLC.
7 secondary outcomes
Response to Therapy as assessed by the physician
Time frame: 24 months from last subject in
Time on treatment by line of therapy and between therapies
Time frame: 24 months from last subject in
Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
Time frame: 24 months from last subject in
Time to symptom deterioration
Time frame: 24 months from last subject in
Symptom Improvement Rate
Time frame: 24 months from last subject in
Duration of Response as defined by the physician
Time frame: 24 months from last subject in
Progression Free Survival
Time frame: 24 months from last subject in
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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.
49 sites in 9 countries: 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 AstraZeneca at 49 sites in 9 countries.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Spain, Italy, China, France, United States and 4 more countries. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (time frame: 24 months from last subject in). 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 8 Jul 2015.