18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE)Primary· From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)
The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorde
Total Participants with Grade 3-4 AE
Group
Value
95% CI
Nivolumab 480mg Q4W
3
Total Participants with Grade 5 AE
Group
Value
95% CI
Nivolumab 480mg Q4W
0
Progression Free Survival (PFS)Secondary· From first dose to the date of the first documented tumor progression (up to approximately 5 months)
Progression free survival (PFS) is defined as the time between the date of randomization and the date of the first documented tumor progression accounting for subsequent therapy, based on BICR (blinded independent central review) assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants will be censored at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the basel
Group
Value
95% CI
Nivolumab 480mg Q4W
3.68
3.06 – 4.50
Objective Response Rate (ORR)Secondary· From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 25 months).
Objective Response Rate (ORR) defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator per RECIST 1.1. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Radiographic tumor assessments will be conducted at Week 8 (+/- 7 days) and every 8 weeks (+/- 7 days) until up to 2 years or until disease progression (or
Group
Value
95% CI
Nivolumab 480mg Q4W
17.1
11.0 – 24.7
Overall Survival (OS)Secondary· From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)
Overall Survival (OS) is defined as the time between the first dosing date and the date of death due to any cause. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.
Group
Value
95% CI
Nivolumab 480mg Q4W
10.58
8.34 – 14.69
Duration of Response (DOR)Secondary· From the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first (up to approximately 48 months).
Duration of Response (DOR) is defined as the time between the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1) as determined by complete response (CR) or partial response (PR), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including palliative local therapy) without a prior reported progression will be censored at the last evaluable tumor assessment prior to or
Group
Value
95% CI
Nivolumab 480mg Q4W
35.45
10.87 – 47.31
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) - Extended CollectionSecondary· From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 25 months)
The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorde
Total Participants with Grade 3-4 AE
Group
Value
95% CI
Nivolumab 480mg Q4W
6
Total Participants with Grade 5 AE
Group
Value
95% CI
Nivolumab 480mg Q4W
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab 480mg Q4W
Serious: 56/129 (43%)
Deaths: 105/129
Serious adverse events (45 terms)
Reaction
System
Nivolumab 480mg Q4W
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Other recruiting trials for Non-Small Cell Lung Cancer
Currently open trials in the same condition.
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· recruiting
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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· not yet recruiting
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· Phase 3
· not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 5 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03090737.