Study 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.
T790M Mutation Positive 2nd Line STandard of cAre Registry
T-STAR
T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
1 other identifier
observational
N/A
9 countries
49
Brief 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 chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2015
Typical duration for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 8, 2015
July 1, 2015
3 years
January 29, 2015
July 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 months from last subject in
Secondary Outcomes (7)
Response to Therapy as assessed by the physician
24 months from last subject in
Time on treatment by line of therapy and between therapies
24 months from last subject in
Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
24 months from last subject in
Time to symptom deterioration
24 months from last subject in
Symptom Improvement Rate
24 months from last subject in
- +2 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (49)
Research Site
Kentucky, Kentucky, United States
Research Site
Maryland City, Maryland, United States
Research Site
Langhorne, Pennsylvania, United States
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Guangzhou, China
Research Site
Jiangsu, China
Research Site
Jilin, China
Research Site
Shanghai, China
Research Site
Shanghai Ruijin Hospital, China
Research Site
Sichuan Cancer Hospital, China
Research Site
Xi'an, China
Research Site
Boulogne-Billancourt, France
Research Site
Bretagne, France
Research Site
La Chaussée-Saint-Victor, France
Research Site
Lille, France
Research Site
Pontoise, France
Research Site
Rhone-Alpes, France
Research Site
Saint-Quentin, France
Research Site
Esslingen am Neckar, Germany
Research Site
Catania, Italy
Research Site
Ferrara, Italy
Research Site
Messina, Italy
Research Site
Modena, Italy
Research Site
Napoli, Italy
Research Site
Padua, Italy
Research Site
Parma, Italy
Research Site
Perugia, Italy
Research Site
Rome, Italy
Research Site
Torino, Italy
Research Site
Groningen, Netherlands
Research Site
Barnaul, Russia
Research Site
Saint Petersburg, Russia
Research Site
A Coruña, Spain
Research Site
Alicante, Spain
Research Site
Badalona, Spain
Research Site
Barcelona, Spain
Research Site
León, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Ourense, Spain
Research Site
Pamplona, Spain
Research Site
Santander, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Vizcaya, Spain
Research Site
Linkou District, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
February 23, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 8, 2015
Record last verified: 2015-07