Trial Outcomes & Findings for Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NCT NCT04475939)

The results presented are until the primary completion date. Additional safety results will be submitted within a year of study completion.

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer

PFS is defined as the time from the date of randomization to the date of first objectively documented disease progression (PD) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

OS is defined as the interval of time from the date of randomization to the date of death due to any cause.

OS is defined as the interval of time from the date of randomization to the date of death due to any cause.

TTP in the CNS is defined as the time from the date of randomization until the earliest date of documented PD in the CNS as assessed by BICR using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.

PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by investigators using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

PFS is defined as the time from the date of randomization to the date of first radiographic progression in the CNS as determined by BICR using RANO-BM criteria or until death due to any cause (whichever occurs first). This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.

PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Participants were evaluated by PD-L1 status: Tumor Cells (TCs) ≥1% and TCs \<1%/Not Evaluable.

OS is defined as the interval of time from the date of randomization to the date of death due to any cause. Participants were evaluated by PD-L1 status: Tumor Cells (TCs) ≥1% and TCs \<1%/Not Evaluable.

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. MCID status: Functional scales \& GHS/QoL (Improved: ≥ +10; Stable: \> -10 and \< +10; Worsened: ≤ -10) and Symptom scales (Improved: ≤ -10; Stable: \> -10 and \< +10; Worsened: ≥ +10)