Return to Clinical Trials Search Results

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

Primary Outcome Measures: 1.Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC [ Time Frame: up to 5 years ] Secondary: 1.Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC [ Time Frame: up to 5 years ] 2.Overall Survival (OS) [ Time Frame: up to 6 years ] 3.Lung cancer-specific mortality [ Time Frame: up to 6 years ] 4.Peak Plasma Concentration (Cmax) [ Time Frame: up to 27 months ] 5.Detection of ADA neutralising antibodies titers [ Time Frame: up to 30 months ] 6.Health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30 [ Time Frame: up to 6 years ] 7.Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1 [ Time Frame: at 24 months following randomization ] 8.Time to progression (TTP) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ] 9.Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ] 10.Time from randomisation to second progression (PFS2) as defined by local standard clinical practice [ Time Frame: up to 6 years ] 11.Trough Concentration (Ctrough) [ Time Frame: up to 27 months ] 12.Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab compared to placebo after administration of SBRT [ Time Frame: up to 27 months]

Primary Outcome Measures: 1.Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC [ Time Frame: up to 5 years ] Secondary: 1.Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC [ Time Frame: up to 5 years ] 2.Overall Survival (OS) [ Time Frame: up to 6 years ] 3.Lung cancer-specific mortality [ Time Frame: up to 6 years ] 4.Peak Plasma Concentration (Cmax) [ Time Frame: up to 27 months ] 5.Detection of ADA neutralising antibodies titers [ Time Frame: up to 30 months ] 6.Health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30 [ Time Frame: up to 6 years ] 7.Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1 [ Time Frame: at 24 months following randomization ] 8.Time to progression (TTP) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ] 9.Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ] 10.Time from randomisation to second progression (PFS2) as defined by local standard clinical practice [ Time Frame: up to 6 years ] 11.Trough Concentration (Ctrough) [ Time Frame: up to 27 months ] 12.Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab compared to placebo after administration of SBRT [ Time Frame: up to 27 months]