A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Advanced (FIGO Stage III-IV) High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy

INTERVENTION: Trade Name: Lynparza Tablet 100 mg Product Name: Olaparib 100 mg Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: olaparib CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Lynparza Tablet 150 mg Product Name: Olaparib 150 mg Product Code: AZD2281 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: olaparib CAS Number: 763113‐22‐0 Current Sponsor code: AZD2281 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Olaparib Maintenance Monotherapy in Participants with BRCAWild Type Ovarian Cancer Following Response toFirst‐line Platinum‐based Chemotherapy Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III or IV ovarian cancer (including fallopian tube and peritoneal cancers) with a BRCAwt HRD positive tumour and a CR or PR following standard first line platinum based chemotherapy treatment.; To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers) with a BRCAwt tumour and a CR or PR following standard first‐line platinum‐based chemotherapy treatment. Primary end point(s): PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause. Secondary Objective: To demonstrate superiority of olaparib as maintenance treatment relative to placebo in participants with Stage III or IV ovarian cancer (including fallopian tube and peritoneal cancers) and a CR or PR following standard first line platinum based chemotherapy treatment with a BRCAwt HRD positive/BRCAwt tumour, by assessment of:; a) Overall survival ; b) TFST; c) second progression free survival (PFS2); d) TSST; e) time to study intervention discontinuation or death (TDT); f) time to earliest progression by RECIST 1.1 or CA‐125 or death; To assess disease‐related symptoms, functioning, and HRQoL in participants treated with olaparib compared with placebo using the EORTC QLQ C30 questionnaire and its ovarian specific module, EORTC QLQ OV28 in participants with a BRCAwt HRD positive/BRCAwt tumour and a CR or PR following standard first‐line platinum based chemotherapy treatment. Timepoint(s) of evaluation of this end point: randomisation until progression or death due to any cause. SECONDARY OUTCOME: Secondary end point(s): OS is defined as time?from randomisation until the date of death due to any cause. ; TFST is defined as time?randomisation until the start date of the first subsequent anti‐cancer therapy after discontinuation of randomised treatment, or death due to any cause.; PFS2 is defined as time from the randomisation to the earliest of the progression event, subsequent to first subsequent therapy or death.?; TSST is defined as time from randomisation until the start date of the second subsequent anti‐cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.; TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.; Time to earliest progression by RECIST 1.1 or CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1 or CA‐125 progression or death by any cause.; Change from baseline in EORTC QLQ C30 and EORTC QLQ OV28 selected scores. Timepoint(s) of evaluation of this end point: OS: date of death. ; TFST: the first subsequent anti‐cancer therapy after discontinuation of randomised treatment, or death due to any cause.; PFS2: the earliest of the progression event, subsequent to first subsequent therapy or death.?; TSST: the start date of the second subsequent anti‐cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.; TDT: discontinuation of treatment for any reason, including disease progression, toxicity and death.; Time to earliest progression by RECIST 1.1 or CA 125 or death: the earlier date of RECIST 1.1 or CA‐125 progression or death by any cause.; Change from baseline in EORTC QLQ C30 and EORTC QLQ OV28 selected scores. INCLUSION CRITERIA: 1,Participants must be =18 years at the time of (pre‐)screening 2,Histological and staging criteria:Female participants who must have histologically newly diagnosed high‐grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to the International FIGO 2009. 3, Participants are eligible if they fulfil any of the following surgical criteria: ? ‐Stage III: primary debulking surgery with macroscopic residual disease post‐surgery, neoadjuvant chemotherapy, or inoperable. ? ‐Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant chemotherapy, or inoperable. 4, Chemotherapy criteria: ‐Participants must have received platinum‐based chemotherapy consisting of a minimum of 6 treatment cycles and a maximum of 9, however, if platinum‐based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, participants