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

Trial Title: 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

NCT ID: NCT04351555

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed
Osimertinib

Conditions: Keywords:
Resectable; NSCLC; Osimertinib; EGFRm Positive; Neoadjuvant; Adjuvant

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Masking description: The two arms with SoC chemotherapy (placebo plus chemotherapy versus osimertinib plus chemotherapy) will be double-blinded and placebo-controlled. Osimertinib monotherapy arm will be open label, sponsor-blind.

Intervention:

Intervention type: Drug
Intervention name: Osimertinib
Description: Oral
Arm group label: Arm 2: Osimertinib with platinum-based chemotherapy
Arm group label: Arm 3: Osimertinib monotherapy

Other name: AZD9291; TAGRISSO

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Arm group label: Arm 1: Placebo with platinum-based chemotherapy
Arm group label: Arm 2: Osimertinib with platinum-based chemotherapy

Intervention type: Drug
Intervention name: Carboplatin
Description: Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Arm group label: Arm 1: Placebo with platinum-based chemotherapy
Arm group label: Arm 2: Osimertinib with platinum-based chemotherapy

Intervention type: Drug
Intervention name: Placebo
Description: Oral
Arm group label: Arm 1: Placebo with platinum-based chemotherapy

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Arm group label: Arm 1: Placebo with platinum-based chemotherapy
Arm group label: Arm 2: Osimertinib with platinum-based chemotherapy

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

Criteria for eligibility:
Criteria:
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)

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

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Zip: 510095
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City: Guangzhou
Zip: 510120
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Address:
City: Guangzhou
Zip: 510515
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City: Hangzhou
Zip: 310009
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City: Hangzhou
Zip: 310022
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Zip: 650118
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City: Nanchang
Zip: 330006
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City: Nantong
Zip: 226001
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City: Shanghai
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City: Shanghai
Zip: 200433
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City: Wanzhou
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City: Wenzhou
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City: Yangzhou
Zip: 225001
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City: Avignon Cedex
Zip: 84902
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City: Bordeaux
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City: Berlin
Zip: 12351
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City: Bielefeld
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Address:
City: Esslingen a.N.
Zip: 73730
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Name: Research Site

Address:
City: Freiburg
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Address:
City: Gauting
Zip: 82131
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Address:
City: Georgsmarienhuette
Zip: 49124
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Address:
City: Halle
Zip: 06120
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City: Köln
Zip: 51109
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City: Oldenburg
Zip: 26121
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City: Würzburg
Zip: 97067
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City: Namakkal
Zip: 637001
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City: Haifa
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City: Jerusalem
Zip: 91120
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City: Kfar Saba
Zip: 95847
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Address:
City: Petah Tikva
Zip: 49100
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City: Ramat Gan
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City: Tel Aviv
Zip: 62748
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Zip: 70124
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City: Firenze
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City: Monza
Zip: 20900
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City: Orbassano
Zip: 10043
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Address:
City: Padova
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Address:
City: Rozzano
Zip: 20089
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Address:
City: Varese
Zip: 21100
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Address:
City: Akashi-shi
Zip: 673-8558
Country: Japan

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Address:
City: Bunkyo-ku
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Address:
City: Chiba-shi
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Address:
City: Hiroshima-shi
Zip: 734-8551
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Address:
City: Kashiwa
Zip: 227-8577
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Address:
City: Koto-ku
Zip: 135-8550
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Address:
City: Kyoto-shi
Zip: 606-8507
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Name: Research Site

Address:
City: Niigata-shi
Zip: 951-8566
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Name: Research Site

Address:
City: Osaka-shi
Zip: 541-8567
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Address:
City: Osakasayama-shi
Zip: 589-8511
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Address:
City: Sakai-shi
Zip: 591-8555
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Address:
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Address:
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Address:
City: Sunto-gun
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Address:
City: Yokohama-shi
Zip: 241-8515
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Address:
City: Daegu
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Address:
City: Hwasun-gun
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Address:
City: Incheon
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Address:
City: Seoul
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Address:
City: Seoul
Zip: 08308
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Address:
City: Seoul
Zip: 42601
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City: Lima
Zip: 15036
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Address:
City: Lima
Zip: L41
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Address:
City: Lima
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Address:
City: Nizhniy Novgorod
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Address:
City: Obninsk
Zip: 249036
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City: Perm
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City: Saint Petersburg
Zip: 191036
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Name: Research Site

Address:
City: Saint Petersburg
Zip: 197758
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Name: Research Site

Address:
City: Saint-Petersburg
Zip: 197758
Country: Russian Federation

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Address:
City: Barcelona
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City: Madrid
Zip: 28040
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Name: Research Site

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City: Majadahonda
Zip: 28222
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Name: Research Site

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City: Málaga
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Name: Research Site

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City: Winterthur
Zip: 8401
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Name: Research Site

Address:
City: Zürich
Zip: CH-8091
Country: Switzerland

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Name: Research Site

Address:
City: Taichung
Zip: 40201
Country: Taiwan

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Name: Research Site

Address:
City: Taichung
Zip: 40447
Country: Taiwan

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Name: Research Site

Address:
City: Tainan City
Zip: 73657
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Name: Research Site

Address:
City: Taipei City
Zip: 110
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 10002
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 112
Country: Taiwan

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Name: Research Site

Address:
City: Taipei
Zip: 235
Country: Taiwan

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Name: Research Site

Address:
City: Bangkok
Zip: 10330
Country: Thailand

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Name: Research Site

Address:
City: Bangkok
Zip: 10400
Country: Thailand

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Name: Research Site

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

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Name: Research Site

Address:
City: Khon Kaen
Zip: 40002
Country: Thailand

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Name: Research Site

Address:
City: Pathumthani
Zip: 12120
Country: Thailand

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Name: Research Site

Address:
City: Phisanulok
Zip: 65000
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Name: Research Site

Address:
City: Ankara
Zip: 06010
Country: Turkey

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Name: Research Site

Address:
City: Ankara
Zip: 06800
Country: Turkey

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Name: Research Site

Address:
City: Ankara
Zip: 6500
Country: Turkey

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Name: Research Site

Address:
City: Istanbul
Zip: 34010
Country: Turkey

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Name: Research Site

Address:
City: Istanbul
Zip: 34214
Country: Turkey

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Name: Research Site

Address:
City: Malatya
Zip: 44280
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Name: Research Site

Address:
City: Birmingham
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Country: United Kingdom

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Name: Research Site

Address:
City: Liverpool
Zip: L7 8YA
Country: United Kingdom

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Name: Research Site

Address:
City: Hanoi
Zip: 100000
Country: Vietnam

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Name: Research Site

Address:
City: Ho Chi Minh
Zip: 700000
Country: Vietnam

Facility:
Name: Research Site

Address:
City: Ho Chi Minh
Zip: 70000
Country: Vietnam

Start date: December 16, 2020

Completion date: June 13, 2029

Lead sponsor:
Agency: AstraZeneca
Agency class: Industry

Source: AstraZeneca

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04351555