Mobile devices to detect early pneumonitis in stage III NSCLC patients on durvalumab. - ON TRAX

Study identifier:D4194C00008

ClinicalTrials.gov identifier:NCT04381494

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III Non-Small Cell Lung Cancer Patients on Durvalumab

Medical condition

Unresectable Stage III NSCLC

Phase

Phase 4

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 27 Apr 2020

Primary Completion Date: 27 Jan 2022

Study Completion Date: 27 Jan 2022

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 May 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Santa Ana, CA, United States, 92705

Location

Research Site

Westwood, KS, United States, 66205

Location

Research Site

Lacey, WA, United States, 98503

Location

Research Site

Tampa, FL, United States, 33612

Location

Research Site

San Antonio, TX, United States, 78229

Location

Research Site

Plainville, CT, United States, 06062

Location

Research Site

Englewood, CO, United States, 80113

Location

Research Site

Boca Raton, FL, United States, 33486

Arms	Assigned Interventions
Other: Observational/Other Patients will be enrolled after their treating physician has prescribed durvalumab and before they start durvalumab treatment. Patients will receive mobile and wearable devices alongside their durvalumab treatment without any additional interventions.	-

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Mobile devices to detect early pneumonitis in stage III NSCLC patients on durvalumab. - ON TRAX

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=7035ee52-a3a7-4c19-a4bf-70642e355403&fileName=D4194C00008_Protocol_Redacted.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=2138fa46-a8da-4441-97a2-eceaeb1c7369&fileName=D4194C00008_SAP_Redacted.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=42b0fdcc-82c1-46ab-b2a4-e0a31e0c5758&fileName=D4194C00008-CSR_Synopsis.pdf&versionIdentifier=

Trial Results Summaries

Contacts

Contact

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D4194C00008&amp;attachmentIdentifier=7035ee52-a3a7-4c19-a4bf-70642e355403&amp;fileName=D4194C00008_Protocol_Redacted.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D4194C00008&amp;attachmentIdentifier=2138fa46-a8da-4441-97a2-eceaeb1c7369&amp;fileName=D4194C00008_SAP_Redacted.pdf&amp;versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D4194C00008&amp;attachmentIdentifier=42b0fdcc-82c1-46ab-b2a4-e0a31e0c5758&amp;fileName=D4194C00008-CSR_Synopsis.pdf&amp;versionIdentifier=

Trial Results Summaries

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=7035ee52-a3a7-4c19-a4bf-70642e355403&fileName=D4194C00008_Protocol_Redacted.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=2138fa46-a8da-4441-97a2-eceaeb1c7369&fileName=D4194C00008_SAP_Redacted.pdf&versionIdentifier=

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4194C00008&attachmentIdentifier=42b0fdcc-82c1-46ab-b2a4-e0a31e0c5758&fileName=D4194C00008-CSR_Synopsis.pdf&versionIdentifier=