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Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer - Trial NCT06268210

Access comprehensive clinical trial information for NCT06268210 through Pure Global AI's free database. This Phase 2 trial is sponsored by Yonsei University and is currently Not yet recruiting. The study focuses on Non-small Cell Lung Cancer. Target enrollment is 160 participants.

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NCT06268210
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06268210
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Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer (NeoLazer): a Phase II, Randomized, Multi-center Study

Study Focus

Lazertinib+Pemetrexed+Carboplatin

Interventional

drug

Sponsor & Location

Yonsei University

Seoul, South Korea

Timeline & Enrollment

Phase 2

Mar 01, 2024

Jun 01, 2028

160 participants

Primary Outcome

Primary pathological response

Summary

In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and
 safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy
 as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19
 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to
 IIIB. The study is designed to assess the impact on pathological response, as well as
 effectiveness and safety considerations.

ICD-10 Classifications

Secondary malignant neoplasm of lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06268210

Non-Device Trial