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Completed

NCT Number: NCT03117049

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Clinical Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ONO-4538

Drug

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

carboplatin

Drug

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.

paclitaxel

Drug

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.

Bevacizumab

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Approximately 32 months

    PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 32 months

  2. Objective Response Rate (ORR [as Assessed by the IRRC])

    Time frame: Approximately 32 months

    ORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

  3. Disease Control Rate (DCR [as Assessed by the IRRC])

    Time frame: Approximately 32 months

    DCR represents the proportion of subjects whose best overall response was assessed as CR, PR, or stable disease (SD). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

  4. Duration of Response (DOR [as Assessed by the IRRC])

    Time frame: Approximately 32 months

    The lower and upper limits of 95% CI for the median are censored value in the both groups.

  5. Best Overall Response (BOR [as Assessed by the IRRC])

    Time frame: Approximately 32 months

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Apr 17, 2017
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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