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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:
15.07.2021

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 163)

Research Site
33611 Bielefeld
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
45239 Essen
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Research Site
73730 Esslingen a.N.
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyZurückgezogen» Google-Maps
Research Site
70839 Gerlingen
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
51109 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
55131, DE Rheinland-Pfalz
(Rheinland-Pfalz)
GermanyZurückgezogen» Google-Maps
Research Site
90048 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
95403 Santa Rosa
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
10032 New York
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
78229 San Antonio
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
98104 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
04501-000 Ibirapuera
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90035-000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90610-000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
14021-636 Ribeirão Preto
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
22271-110 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
15090-000 São José do Rio Preto
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
04038-034 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
2540488 Viña del Mar
ChileNoch nicht rekrutierend» Google-Maps
Research Site
50612 Gyeongsangnam-do
Korea, Republic ofRekrutierend» Google-Maps
Research Site
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Research Site
603081 Nizhniy Novgorod
Russian FederationRekrutierend» Google-Maps
Research Site
6500 Bellinzona
SwitzerlandNoch nicht rekrutierend» Google-Maps
Research Site
65000 Phisanulok
ThailandNoch nicht rekrutierend» Google-Maps
Research Site
CH63 4JY Bebington
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
70000 Ho Chi Minh
VietnamNoch 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 (ie, 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, 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

- 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 aorta, the oesophagus and/or the heart; 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 residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

2. Event-free survival (EFS) (Time Frame - Up to approximately 42 months after the last patient is randomized):
An event is defined as documented disease progression that precludes surgery or requires non-protocol therapy; recurrence or a new lesion, local or distant (a new primary malignancy confirmed by pathology is not considered to be an EFS event.); death due to any cause

3. Overall Survival (OS) (Time Frame - Up to approximately 5.5 years after the last patient is randomized):
Patients will be followed up to approximately 5.5 years after they are randomized.

4. Disease free survival (DFS) (Time Frame - From date of randomization up to approximately 42 months after date of resection):
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 randomization to 264 weeks post-surgery):
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 randomization to 264 weeks post-surgery):
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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