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JOURNAL ONKOLOGIE – STUDIE
NeoADAURA

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04351555

Studienbeginn:
Dezember 2020

Letztes Update:
25.03.2024

Wirkstoff:
Osimertinib, Cisplatin, Carboplatin, Placebo, Pemetrexed

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Jamie Chaft, MD
Principal Investigator
Memorial Sloan Kettering, USA
Masahiro Tsuboi, MD
Principal Investigator
National Cancer Center Hospital East, Japan
Walter Weder, MD
Principal Investigator
Thoraxchirurgie Bethanien, Switzerland

Kontakt

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

Studienlocations
(3 von 226)

Research Site
33611 Bielefeld
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Research Site
73730 Esslingen a.N.
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Research Site
79106 Freiburg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyAbgeschlossen» Google-Maps
Research Site
06120 Halle
(Sachsen-Anhalt)
GermanyAbgeschlossen» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
51109 Köln
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Research Site
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
92618 Irvine
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
94143 San Francisco
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
90404 Santa Monica
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
95403 Santa Rosa
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
03756 Lebanon
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
11725 Commack
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
10032 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
22031 Fairfax
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Research Site
14784-400 Barretos
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
60135-040 Fortaleza
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
90035-000 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
90610-000 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
52010-075 Recife
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
22271-110 Rio de Janeiro
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
97015-450 Santa Maria
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
01327-001 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
15090-000 São José do Rio Preto
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
04038-034 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
04501-000 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Research Site
4500 Panagyurishte
BulgariaAktiv, nicht rekrutierend» Google-Maps
Research Site
H4A 3J1 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Research Site
7560908 Las Condes
ChileAktiv, nicht rekrutierend» Google-Maps
Research Site
CN-100730 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
Research Site
CN-325000 Wenzhou
ChinaAktiv, nicht rekrutierend» Google-Maps
Research Site
84902 Avignon Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Research Site
5265601 Ramat Gan
IsraelAktiv, nicht rekrutierend» Google-Maps
Research Site
673-8558 Akashi-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
113-8431 Bunkyo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
260-8677 Chiba-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
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
41404 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
21431 Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
02447 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
08308 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
42601 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
50612 Yangsan-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
20230 Aguascalientes
MexicoAktiv, nicht rekrutierend» Google-Maps
Research Site
'14080 Mexico City
MexicoAktiv, nicht rekrutierend» Google-Maps
Research Site
660133 Krasnoyarsk
Russian FederationAbgebrochen» Google-Maps
Research Site
603081 Nizhniy Novgorod
Russian FederationSchwebend» Google-Maps
Research Site
191036 Saint Petersburg
Russian FederationSchwebend» Google-Maps
Research Site
197758 Saint Petersburg
Russian FederationAbgebrochen» Google-Maps
Research Site
197758 Saint-Petersburg
Russian FederationAbgebrochen» Google-Maps
Research Site
197022 St. Petersburg
Russian FederationZurückgezogen» Google-Maps
Research Site
28222 Majadahonda
SpainAktiv, nicht rekrutierend» Google-Maps
Research Site
CH-8091 Zürich
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Research Site
73657 Tainan City
TaiwanAktiv, nicht rekrutierend» Google-Maps
Research Site
50200 Chiang Mai
ThailandAktiv, nicht rekrutierend» Google-Maps
Research Site
40002 Khon Kaen
ThailandAktiv, nicht rekrutierend» Google-Maps
Research Site
12120 Pathumthani
ThailandAktiv, nicht rekrutierend» Google-Maps
Research Site
65000 Phisanulok
ThailandAktiv, nicht rekrutierend» Google-Maps
Research Site
B9 5SS Birmingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
L7 8YA Liverpool
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
M23 9LT Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh
VietnamAktiv, nicht rekrutierend» Google-Maps
Research Site
70000 Ho Chi Minh
VietnamAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant

osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy

alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Male or female, at least 18 years of age. For patients aged <20 years and enrolled in

Japan, a written informed consent should be obtained from the patient and his or her

legally acceptable representative

- Histologically or cytologically documented non-squamous NSCLC with completely

resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer

Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).

- Complete surgical resection of the primary NSCLC must be deemed achievable, as

assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in

oncologic procedures).

- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no

deterioration over the previous 2 weeks prior to baseline or day of first dosing

- A tumour which harbours one of the 2 common EGFR mutations known to be associated with

EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR

mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q).

Exclusion Criteria:

- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required

steroid treatment, or any evidence of clinically active ILD.

- History of another primary malignancy (including any known or suspected synchronous

primary lung cancer), except for the following: Malignancy treated with curative

intent and with no known active disease ≥2 years before the first dose of

investigational product (IP) and of low potential risk for recurrence; Adequately

treated non-melanoma skin cancer or lentigo malignancy without evidence of disease;

Adequately treated carcinoma in situ without evidence of disease; Any synchronous

Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery

for the Stage II to IIIB N2 lung tumour.

- Patients who have pre-operative radiotherapy treatment as part of their care plan

- Mixed small cell and NSCLC histology

- Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC

- T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus,

the heart, and/or the vertebral body; and/or any bulky N2 disease.

- Patients who are candidates to undergo only segmentectomies or wedge resections

- Prior treatment with any systemic anti-cancer therapy for NSCLC including

chemotherapy, biologic therapy, immunotherapy, or any investigational drug

- Prior treatment with EGFR-TKI therapy

- Current use of (or unable to stop use prior to receiving the first dose of study

treatment) medications or herbal supplements known to be strong inducers of cytochrome

P450 (CYP) 3A4 (at least 3 weeks prior)

Studien-Rationale

Primary outcome:

1. Major Pathological Response (MPR) (Time Frame - From date of randomization to an average of 12 weeks after the first dose):
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery



Secondary outcome:

1. Pathological complete response (pCR) (Time Frame - From date of randomization to an average of 12 weeks after the first dose):
Defined as absence of any viable cancer cells in the dissected tumour samples, including the main tumour, lymph nodes, and margins as assessed per central pathology laboratory post-surgery

2. Event-free survival (EFS) (Time Frame - From date of randomization up to approximately 5.5 years after the last patient is randomized):
An event is defined as documented disease progression that precludes surgery or prevents completion of definitive surgery; recurrence or a new lesion, local or distant (a new primary malignancy, confirmed by pathology if clinically feasible, is not considered to be an EFS event); death due to any cause

3. Overall Survival (OS) (Time Frame - From date of randomization up to approximately 5.5 years after the last patient is randomized):
OS will be defined as the time from the date of randomisation until death due to any cause

4. Disease free survival (DFS) (Time Frame - From date of randomization up to approximately 5.5 years after the last patient is randomized):
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.

5. Downstaging (Time Frame - From date of randomization to an average of 12 weeks after the first dose):
Measured using pathologic mediastinal lymph node evaluation

6. Difference between treatment arms in change from baseline in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items) (Time Frame - From date of randomization up to approximately 5.5 years after the last patient is randomized):
Assess disease-related symptoms, functioning, and global health status/quality-of-life in patients

7. Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA (Time Frame - Baseline)

8. Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples (Time Frame - Baseline)

9. PK plasma concentrations of osimertinib (Time Frame - From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days))

10. Difference between treatment arms in change from baseline in EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items) (Time Frame - From date of randomization up to approximately 5.5 years after the last patient is randomized):
Assess lung cancer-associated symptoms and side effects from conventional chemotherapy and radiotherapy

Studien-Arme

  • Placebo Comparator: Arm 1: Placebo with platinum-based chemotherapy
    Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
  • Experimental: Arm 2: Osimertinib with platinum-based chemotherapy
    Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
  • Experimental: Arm 3: Osimertinib monotherapy
    Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)

Geprüfte Regime

  • Osimertinib (AZD9291; TAGRISSO):
    Oral
  • Cisplatin:
    Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
  • Carboplatin:
    Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
  • Placebo:
    Oral
  • Pemetrexed:
    Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles

Quelle: ClinicalTrials.gov


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