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Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

NCT03117049•Ono Pharmaceutical Co. Ltd

Summary

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
•Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
•Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
•Subjects who are able to provide tumor tissue specimens.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria

•Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.
•Subjects with known ALK translocations.
•Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
•Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
•Subjects with multiple cancer.

Locations (135)

Aichi Clinical Site2

Nagoya, Aichi-ken, Japan

Aichi Clinical Site3

Nagoya, Aichi-ken, Japan

Aichi Clinical Site4

Nagoya, Aichi-ken, Japan

Aichi Clinical Site

Nagoya, Aichi-ken, Japan

Aichi Clinical Site

Toyoake, Aichi-ken, Japan

Aomori Clinical Site2

Hirosaki, Aomori, Japan

Aomori Clinical Site

Hirosaki, Aomori, Japan

Chiba Clinical Site

Yachiyo, Chiba, Japan

Ehime Clinical Site

Matsuyama, Ehime, Japan

Fukuoka Clinical Site

Iizuka, Fukuoka, Japan

Key Dates

Start Date

June 13, 2017

Primary Completion Date

February 10, 2020

Completion Date

December 4, 2023

Last Updated

May 6, 2024

Enrollment

550

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

ONO-4538

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Bevacizumab

DRUG

Placebo

DRUG

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

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

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)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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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: May 6, 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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Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Inclusion Criteria

Exclusion Criteria

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

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)

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)