Clinical trial NCT02368990: T790M Mutation Positive 2nd Line STandard of cAre Registry
Official title: T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
T790M
EGFR
TKI Resistance
Non Small Cell Lung Cancer
AZD9291
Clovis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2015-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 24 months from last subject in
Secondary outcomes:
measure: Response to Therapy as assessed by the physician
timeFrame: 24 months from last subject in
measure: Time on treatment by line of therapy and between therapies
timeFrame: 24 months from last subject in
measure: Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
timeFrame: 24 months from last subject in
measure: Time to symptom deterioration
timeFrame: 24 months from last subject in
measure: Symptom Improvement Rate
timeFrame: 24 months from last subject in
measure: Duration of Response as defined by the physician
timeFrame: 24 months from last subject in
measure: Progression Free Survival
timeFrame: 24 months from last subject in
Other outcomes:
Locations:
city: Kentucky
country: United States
facility: Research Site
state: Kentucky
city: Maryland
country: United States
facility: Research Site
state: Maryland
city: Langhorne
country: United States
facility: Research Site
state: Pennsylvania
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Jiangsu
country: China
facility: Research Site
city: Jilin
country: China
facility: Research Site
city: Shanghai Ruijin Hospital
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Sichuan Cancer Hospital
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Bretagne
country: France
facility: Research Site
city: La Chaussee-Saint-Victor
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Rhone-Alpes
country: France
facility: Research Site
city: Saint Quentin
country: France
facility: Research Site
city: Esslingen
country: Germany
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint- Petersburg
country: Russian Federation
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: La Coruna
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Vizcaya
country: Spain
facility: Research Site
city: LinKou
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
References: