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JOURNAL ONKOLOGIE – STUDIE
ADAURA2

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Rekrutierend

NCT-Nummer:
NCT05120349

Studienbeginn:
Februar 2022

Letztes Update:
24.04.2024

Wirkstoff:
Osimertinib, Placebo

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Jonathan Goldman, MD
Principal Investigator
UCLA Department of Medicine
Yasuhiro Tsutani, MD, PhD
Principal Investigator
Kindai University Facility of Medicine
Jie He, MD, PhD
Principal Investigator
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS)

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 184)

Research Site
73730 Esslingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
30625 Hannover
(Niedersachsen)
GermanyZurückgezogen» Google-Maps
Research Site
23538 Lübeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
260-0877 Chiba-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
812-8582 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
734-8551 Hiroshima-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
606-8507 Kyoto-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
951-8566 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
589-8511 Osakasayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
980-0873 Sendai-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
160-0023 Shinjuku-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
411-8777 Sunto-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
641-8510 Wakayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofZurückgezogen» Google-Maps
Research Site
42415 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
52727 Jinju-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
03082 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
07061 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
16247 Suwon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
16499 Suwon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
59100 Kuala Lumpur
MalaysiaAktiv, nicht rekrutierend» Google-Maps
Research Site
10450 Pulau Pinang
MalaysiaAktiv, nicht rekrutierend» Google-Maps
Research Site
46050 Selangor
MalaysiaAktiv, nicht rekrutierend» Google-Maps
Research Site
603126 Nizhny Novgorod
Russian FederationZurückgezogen» Google-Maps
Research Site
630099 Novosibirsk
Russian FederationZurückgezogen» Google-Maps
Research Site
191036 Saint Petersburg
Russian FederationAbgebrochen» Google-Maps
Research Site
197022 Saint Petersburg
Russian FederationZurückgezogen» Google-Maps
Research Site
197758 Saint Petersburg
Russian FederationZurückgezogen» Google-Maps
Research Site
169610 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Research Site
308433 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Research Site
40002 Khon Kaen
ThailandAktiv, nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh city
VietnamAktiv, nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh
VietnamAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study

assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with

stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour

resection. All participants must have had a tumour which harbours one of the 2 common EGFR

mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms:

osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria

is met.

Ein-/Ausschlusskriterien

Inclusion Criteria

1. Male or female, at least ≥ 18 years.

2. NSCLC, of non-squamous histology.

3. Stage IA2 or IA3 disease, based on TNM8 classification.

4. Complete surgical resection (R0) of the primary NSCLC by lobectomy, bilobectomy,

segmentectomy or sleeve resection.

5. Complete recovery from surgery at the time of randomisation. Study intervention cannot

commence within 4 weeks following surgery. No more than 12 weeks may have elapsed

between surgery and randomisation for participants.

6. World Health Organization performance status of 0 or 1.

7. Provision of tumour sample for central pathology assessment of pathologic risk factors

and to assess EGFR mutation status prior to randomisation.

8. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR

Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.

9. Minimum life expectancy of > 6 months.

10. 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. Male subjects must be willing to

use barrier contraception.

Exclusion Criteria

1. Mixed small cell and non-small cell cancer history.

2. Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy or

only wedge resection.

3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled

hypertension and active bleeding diatheses; or active infection including HCV and HIV

or active uncontrolled HBV infection.

4. History of another primary malignancy, including any known or suspected synchronous

primary lung cancer except for malignancy treated with curative intent with no known

active disease ≥ 5 years before the first dose of study intervention and of low

potential risk for recurrence.

5. Any of the following cardiac criteria:

- Mean resting QTcF interval > 470 ms, obtained from triplicate ECGs performed at

screening.

- Any abnormalities in rhythm, conduction, or morphology of resting ECG,

- Any factors that increase the risk of QTcF prolongation or risk of arrhythmic

events.

6. History of interstitial lung disease.

7. Inadequate bone marrow reserve or organ function.

8. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of

starting study intervention.

9. Prior treatment with any anticancer therapy for NSCLC (including chemotherapy,

radiotherapy, immunotherapy, and EGFR-TKIs).

10. Major surgery or significant traumatic injury within 4 weeks of the first dose of

study intervention.

11. Participants currently receiving medications or herbal supplements known to be strong

inducers of CYP3A4.

Studien-Rationale

Primary outcome:

1. Disease-Free Survival (DFS) in high-risk stratum (Time Frame - From date of randomisation up to approximately 10 years):
DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first. Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.



Secondary outcome:

1. Disease-Free Survival (DFS) in overall population (Time Frame - From date of randomisation up to approximately 10 years):
DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

2. Overall Survival (OS) in high-risk stratum and the overall population (Time Frame - From date of randomization up to approximately 10 years):
OS is defined as the time from the date of randomisation until death due to any cause.

3. PK plasma concentrations of osimertinib and of metabolite AZ5104 in overall population (Time Frame - From date of randomisation up to approximately 10 years):
Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.

4. Impact of osimertinib versus placebo on physical functioning (Time Frame - From date of randomisation up to approximately 10 years):
Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey

5. Central Nervous System (CNS) Disease-Free Survival (DFS) in both the high-risk stratum and the overall population (Time Frame - From date of randomisation up to approximately 10 years):
CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.

6. Safety and tolerability in overall population (Time Frame - From date of randomisation up to approximately 10 years):
AEs graded by CTCAE version 5.0

Studien-Arme

  • Experimental: Osimertinib
    Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
  • Placebo Comparator: Placebo
    Matching placebo for osimertinib, orally, once daily

Geprüfte Regime

  • Osimertinib (AZD9291; TAGRISSO):
    The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.
  • Placebo:
    Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.

Quelle: ClinicalTrials.gov


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