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RECRUITINGPHASE2

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Neoadjuvant Osimertinib Plus Chemotherapy for EGFR-mutant Stage III N2 Non-squamous Non-small Cell Lung Cancer

NCT05011487•Sun Yat-sen University

Summary

This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically documented N2 positive non-squamous NSCLC with resectable (Stage IIIA or T3-4N2 IIIB) 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, specialized 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
•T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease deemed unresectable
•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)

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 13, 2021

Primary Completion Date

September 1, 2023

Completion Date

September 1, 2028

Last Updated

January 16, 2024

Enrollment

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Osimertinib

DRUG

Cisplatin

DRUG

Pemetrexed

DRUG

Contacts

Hong Yang, Ph.D.,M.D.

CONTACT

13560405144 yanghong@sysucc.org.cn

Jiyang Chen, Ph.D.,M.D.

CONTACT

008618826238208 chenjy1@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)