OSIMERTINIB for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol"}
• {"criterion_text":"- Male patients must be willing to use barrier contraception"}
• {"criterion_text":"- Pathologically confirmed non-squamous NSCLC (Non-small cell lung cancer)"}
• {"criterion_text":"- Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy"}
• {"criterion_text":"- Evidence of radiological extracranial disease progression following (Investigator-assessed) response or stable disease (SD) for ≥ 6 months during first line osimertinib treatment but who have not received further, subsequent treatment."}
• {"criterion_text":"- Tumor known to harbor 1 of the 2 or both common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M"}
• {"criterion_text":"- World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks."}
• {"criterion_text":"- Life expectancy >12 weeks at Day 1"}
• {"criterion_text":"- At least 1 lesion, not previously irradiated that can be accurately measured"}
• {"criterion_text":"- Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening"}

Exclusion criteria

• {"criterion_text":"- Clinical or radiological evidence of CNS progression on first-line osimertinib"}
• {"criterion_text":"- Past medical history of ILD/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis."}
• {"criterion_text":"- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of IP"}
• {"criterion_text":"- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting IP, with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy"}
• {"criterion_text":"- More than 4 weeks elapsed since last dose of osimertinib by date of randomization"}

Primary endpoints

• {"endpoint_text":"- PFS is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per RECIST 1.1 (for extracranial progression) and CNS RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause","definition_or_measurement_approach":"Time from randomization until progression (intracranial or extracranial, whichever occurs first) per RECIST 1.1 (extracranial) and CNS RECIST 1.1 (intracranial) as assessed by the Investigator at local site, or death due to any cause"}

Secondary endpoints

• {"endpoint_text":"- Intracranial PFS is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause","definition_or_measurement_approach":"Time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site, or death due to any cause"}
• {"endpoint_text":"- Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause","definition_or_measurement_approach":"Time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site, or death due to any cause"}
• {"endpoint_text":"- OS is defined as the length of time from randomization until the date of death due to any cause","definition_or_measurement_approach":"Time from randomization until date of death due to any cause"}

Germany

Earliest CTIS Part Ii Submission Date

31-07-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

47

Number Of Sites

6

Number Of Participants

53

Spain

Earliest CTIS Part Ii Submission Date

31-07-2024

Latest Decision Or Authorization Date

05-05-2025

Processing Time Days

278

Number Of Sites

11

Number Of Participants

49

Italy

Earliest CTIS Part Ii Submission Date

31-07-2024

Latest Decision Or Authorization Date

20-05-2025

Processing Time Days

293

Number Of Sites

8

Number Of Participants

53

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: [1,10,11,12,13,15 (Vendor Management and Clinical Trial Supplies and Logistics),2,5,6,8]; contact email Clinicaltrial.Enquiries@parexel.com

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes present in record: [1,10,11,12,13,15 (Vendor Management and Clinical Trial Supplies and Logistics),2,5,6,8]; contact: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}