Clinical trial

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

Name

ONO-4538-52

Description

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.

Trial arms

Trial start

2017-06-13

Estimated PCD

2020-02-10

Trial end

2023-12-04

Status

Completed

Phase

Early phase I

Treatment

ONO-4538

360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Arms:

ONO-4538 group

Carboplatin

Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Arms:

ONO-4538 group, Placebo group

Paclitaxel

Arms:

ONO-4538 group, Placebo group

Bevacizumab

Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Arms:

ONO-4538 group, Placebo group

Placebo

Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Arms:

Placebo group

Size

550

Primary endpoint

Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)

Approximately 32 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 550, 'type': 'ACTUAL'}}

Updated at

2024-05-06

1 organization

5 drugs

1 indication

Organization

Drug

Drug

Drug

Drug

Drug

Indication