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Clinical Trials in India / NCT04351555
Active, not recruiting Phase 3

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

NCT04351555 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2020-12-16
Last updated
2026-09-09

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

OsimertinibCisplatinCarboplatinPlaceboPemetrexed

Osimertinib: 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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (158)

FacilityCityRegionStatus
Research Site Duarte California
Research Site Irvine California
Research Site San Francisco California
Research Site Santa Monica California
Research Site Santa Rosa California
Research Site Boston Massachusetts
Research Site Lebanon New Hampshire
Research Site Commack New York
Research Site New York New York
Research Site Houston Texas
Research Site Fairfax Virginia
Research Site Seattle Washington
Research Site Graz Austria
Research Site Vienna Austria
Research Site Barretos Brazil
Research Site Fortaleza Brazil
Research Site Jaú Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Recife Brazil
Research Site Rio de Janeiro Brazil
Research Site Santa Maria Brazil
Research Site São José do Rio Preto Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Panagyurishte Bulgaria
Research Site Pleven Bulgaria
Research Site Sofia Bulgaria
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Las Condes Chile
Research Site Santiago Chile
Research Site Santiago Chile
Research Site Beijing China
Research Site Beijing China
Research Site Beijing China
Research Site Changsha China
Research Site Changsha China
Research Site Chengdu China

+ 118 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04351555 on ClinicalTrials.gov ↗ ← All trials in India