A randomized, controlled, multicenter three-arm Phase III study of neoadjuvant therapy with Osimertinib as monotherapy or in combination with chemotherapy versus standard chemotherapy alone for the treatment of patients with resectable non-small cell lung cancer with epidermal growth factor receptor mutation (NeoADAURA)

Austria, Brazil, Bulgaria, Canada, Chile, China, France, Germany, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam (ICTRP)

ID di studio ICTRP
NCT04351555 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA) (BASEC)

Titolo accademico
A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (ICTRP)

Titolo pubblico
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 (ICTRP)

Malattie studiate
Non-Small Cell Lung Cancer (ICTRP)

Intervento studiato
Drug: OsimertinibDrug: CisplatinDrug: CarboplatinDrug: PlaceboDrug: Pemetrexed (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)

Criteri di inclusione/esclusione
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) (ICTRP)

non disponibile

Endpoint primari e secondari
Major Pathological Response (MPR) (ICTRP)

Pathological complete response (pCR);Event-free survival (EFS);Overall Survival (OS);Disease free survival (DFS);Downstaging;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);Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA;Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples;PK plasma concentrations of osimertinib;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) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Jamie Chaft, MD;Masahiro Tsuboi, MD;Walter Weder, MD, Memorial Sloan Kettering, USA,National Cancer Center Hospital East, Japan,Thoraxchirurgie Bethanien, Switzerland (ICTRP)

ID secondari
2022-502606-33-00, 2020-000058-89, D516AC00001 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04351555 (ICTRP)