T790M Mutation Positive 2nd Line STandard of cAre Registry

Non Small Cell Lung Cancer Clinical Trial

— T-STAR  

Official title:

T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02368990
• Other study ID #: D5160R00001
• Status: Withdrawn
• Phase: N/A
• First received: January 29, 2015
• Last updated: July 6, 2015
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review BoardChina: Ethics CommitteeFrance: French Data Protection AuthorityFrance: The Commission nationale de l’informatique et des libertésGermany: Ministry of HealthGermany: Ethics CommissionItaly: The Italian Medicines AgencyItaly: Ethics CommitteeJapan: Institutional Review BoardMexico: Ministry of HealthMexico: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Russia: Ethics CommitteeSpain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Institutional Review BoardTaiwan: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Institute for Health ResearchUnited States: Institutional Review Board
• Study type: Observational

Clinical 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 chemotherapy (Pemetrexed + Cisplatin /Carboplatin).

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
China	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	Xian
France	Research Site	Boulogne Billancourt
France	Research Site	Bretagne
France	Research Site	La Chaussee-Saint-Victor
France	Research Site	Lille
France	Research Site	Pontoise
France	Research Site	Rhone-Alpes
France	Research Site	Saint Quentin
Germany	Research Site	Esslingen
Italy	Research Site	Catania
Italy	Research Site	Ferrara
Italy	Research Site	Messina
Italy	Research Site	Modena
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Parma
Italy	Research Site	Perugia
Italy	Research Site	Rome
Italy	Research Site	Torino
Netherlands	Research Site	Groningen
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint- Petersburg
Spain	Research Site	Alicante
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	La Coruna
Spain	Research Site	Leon
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Ourense
Spain	Research Site	Pamplona
Spain	Research Site	Santander
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Vizcaya
Taiwan	Research Site	LinKou
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
United States	Research Site	Kentucky	Kentucky
United States	Research Site	Langhorne	Pennsylvania
United States	Research Site	Maryland	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Countries where clinical trial is conducted

United States,  China,  France,  Germany,  Italy,  Netherlands,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No
Secondary	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.	24 months from last subject in	No