ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

NCT02175017 | Completed Phase 2 Results

• 1 other identifier: ONO-4538-09
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.

Conditions

Advanced Non-small Cell Lung Cancer (NSCLC)

Keywords

ONO-4538; Advanced non-small cell lung cancer (NSCLC); nivolumab

Outcome Measures

Primary Outcomes (1)

• Response Rate (Centrally Assessed)

  Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)\*100. 95% Confidence interval (CI) was calculated by Wilson method.

  Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.

Secondary Outcomes (4)

• Response Rate (Investigator-assessed)

  Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.

• Overall Survival

  Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.

• Progression Free Survival (Centrally Assessed)

  Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.

• Duration of Response (Centrally Assessed)

  Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.

Study Arms (2)

ONO-4538 for squamous non-small-cell lung cancer (NSCLC)

EXPERIMENTAL

In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.

Drug: ONO-4538

ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC)

EXPERIMENTAL

In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.

Drug: ONO-4538

Interventions

ONO-4538 DRUG

ONO-4538 Study in Patients With Squamous NSCLC

Also known as: nivolumab

ONO-4538 for squamous non-small-cell lung cancer (NSCLC)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 20 years of age
• Histologically or cytologically confirmed non-small cell lung cancer
• Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
• Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

You may not qualify if:

• Current or prior severe hypersensitivity to another antibody product
• Multiple primary cancers

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (10)

Goyang-si Clinical Site 103

Goyang-si, Gyeonggi-do, South Korea

Location

Seongnam-si Clinical Site 104

Seongnam-si, Gyeonggi-do, South Korea

Location

Cheongju-si Clinical Site 106

Cheongju-si, North Chungcheong, South Korea

Location

Incheon Clinical Site 102

Incheon, South Korea

Location

Seoul Clinical Site 101

Seoul, South Korea

Location

Seoul Clinical Site 107

Seoul, South Korea

Location

Seoul Clinical Site 108

Seoul, South Korea

Location

Seoul Clinical Site 109

Seoul, South Korea

Location

Seoul Clinical Site 110

Seoul, South Korea

Location

Ulsan Clinical Site 105

Ulsan, South Korea

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Information Center
• Organization: Ono Pharmaceutical Co., Ltd.

clinical_trial@ono-pharma.com

Study Officials

• Mitsunobu Tanimoto

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (10)