Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TAGRISSO
Product Name: Osimertinib 80 mg
Product Code: AZD9291
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Osimertinib
CAS Number: 1421373-66-1
Current Sponsor code: AZD92
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. 2) Pathologically confirmed non-squamous NSCLC (Non-small cell lung cancer ) 3) 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. 4) Evidence of radiological extracranial disease progression following response with first line osimertinib treatment but who have not received further, subsequent treatment. 5) World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks. 6) Life expectancy >12 weeks at Day 1. 7) At least 1 lesion, not previously irradiated. 8) Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling criteria at screening. 9) Male patients must be willing to use barrier contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 122 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 82
Exclusion criteria
Exclusion criteria: - Clinical or radiological evidence of CNS progression on first-line osimertinib - Past medical history of ILD/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis - Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of IP - Any unresolved toxicities from prior extracranial therapy (eg, adjuvant chemotherapy) greater than CTCAE Grade 1 at the time of starting IP, with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy. - More than 4 weeks elapsed since last dose of osimertinib by date of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on PFS;Secondary Objective: To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on intracranial PFS in patients with baseline brain metastases and patients without baseline brain metastases To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on extracranial PFS To compare the efficacy of chemotherapy plus osimertinib treatment relative to chemotherapy plus placebo based on OS;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: approximately 39 months after the first patient is randomized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 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 OS is defined as the length of time from randomization until the date of death due to any cause;Timepoint(s) of evaluation of this end point: Approximately 45 months after the first patient is randomized. | — |
Countries
Austria, China, Germany, Israel, Italy, Spain, United States
Contacts
Public ContactInformation Centre
AstraZeneca AB
Outcome results
None listed