A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

Phase 3

Completed

• Conditions: Lung Cancer; Non-Small Cell Lung Cancer
• Interventions: Biological: Nivolumab

• Registration Number: NCT03195491
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2017-12-25
• Primary Completion: 2021-06-08
• Study Completion: 2021-06-08
• Results First Submitted: 2022-06-08
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Results First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
• 1 to 2 prior systemic therapies
• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
• Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
• Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

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Exclusion Criteria

• Women with a positive pregnancy test at enrollment or prior to administration of study medication
• Participants with active central nervous system metastases
• Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
• Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
• Participants with carcinomatous meningitis

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monotherapy	Nivolumab	Nivolumab administered every two weeks

Primary Outcome Measures

Name	Time	Method
Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events	From first dose up to 100 days post dose, up to approximately 36 months	Number of non-HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in non-HBV infected participants. To evaluate safety and tolerability in non-HBV infected participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after one prior systemic therapy and are treated with nivolumab monotherapy with an infusion duration of 30 minutes. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Serious Adverse Events (SAEs)	From first dose to 100 days post last dose, up to 36 months	Number of Participants experiencing SAEs are tabulated using worst grade per NCI CTCAE v.4 criteria by system organ class and MedDRA preferred term.
Objective Response Rate	From the first dose date up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. Up to approximately 36 months	Objective Response Rate (ORR) is defined as the percentage of all treated subjects whose best overall response (BOR) from baseline is either a CR or PR per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the first dose date and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For subjects without documented progression or subsequent anticancer therapy, all available response designations will contribute to the BOR determination. For subjects who continue nivolumab beyond progression, the BOR should be determined based on response designations recorded at the time of the initial RECIST 1.1 defined progression.
Progression-Free Survival (PFS)	From the first dose up to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 30 months	PFS is the time from first dose to the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who die without a reported prior progression are considered to have progressed on their death date. Participants who did not progress or die will be documented on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be documented on their first dose date. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be documented at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Participants Experiencing Adverse Events (AEs)	From first dose up to 100 days post dose, up to approximately 36 months	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests	From first dose up to 100 days post last dose, up to approximately 36 months	Number of Participants experiencing laboratory abnormalities are defined as on-study lab parameters summarized by using the worst grade per NCI CTCAE v.4 criteria
Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests	From randomization to 100 days post last dose, up to 36 months	Number of participants experiencing laboratory abnormalities are defined as on-study lab parameters summarized by using the worst grade per NCI CTCAE v.4 criteria
Duration of Tumor Response	From the date of first confirmed response to the date of the first documented tumor progression, up to approximately 30 months	Duration of Response (DOR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who neither progress nor die will be documented on the date of their last assessment. The censoring algorithm for DOR will be the same as used for PFS definition. This endpoint will only be evaluated for participants with the best overall response of complete response or partial response.
Time to Treatment Failure (TTF)	From treatment assignment to disease progression, death or last dose date, up to approximately 16 months	Time to Treatment Failure is defined as the minimum of the time from treatment assignment to disease progression (determined by investigator assessments using RECIST 1.1), death or last dose date if a participant progressed, died or discontinued from treatment for any reasons other than "maximum clinical benefit" and "administrative reasons by sponsor". TTF is censored at the last dose date for participants who continued on treatment without progression (per RECIST 1.1) or death at the time of the database lock. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC).
Number of HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events	From first dose up to 100 days post dose, up to approximately 36 months	Number of HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in HBV participants. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Overall Survival (OS)	From the first dose up to the date of death. Participants without documentation of death will be censored on the late date known to be alive, up to approximately 32 months	Overall survival (OS) is defined as the time from the first dosing date to the date of death. Participants without documentation of death will be recorded on the last date the participant was known to be alive. Tumor PD-L1 protein expression was measured by immunohistochemistry (IHC).

Trial Locations

Locations (2)

Local Institution; 🇹🇭 Khon Kaen, Thailand

Local Institution - 0017; 🇨🇳 Changsha, Hunan, China