A Randomized double-blind Phase II trial evaluating maintenance olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer

INTERVENTION: Trade Name: Lynparza Product Name: Olaparib Product Code: AZD2281 Pharmaceutical Form: Coated tablet INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: Lynparza Product Name: Olaparib Product Code: AZD2281 Pharmaceutical Form: Coated tablet INN or Proposed INN: Olaparib CAS Number: 763113‐22‐0 Other descriptive name: OLAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Advanced non‐small cell lung cancer ; MedDRA version: 18.0 Level: LLT Classification code 10025052 Term: Lung cancer non‐small cell stage III System Organ Class: 100000004864 ; MedDRA version: 18.0 Level: LLT Classification code 10025055 Term: Lung cancer non‐small cell stage IV System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: To evaluate the anti‐tumor activity of maintenance olaparib in platinum‐sensitive NSCLC as measured by PFS from randomization according to RECIST criteria v1.1 Primary end point(s): Progression Free Survival Secondary Objective: ?To evaluate the anti‐tumor activity of maintenance olaparib as measured by overall response rate, disease control rate and overall survival; ?To evaluate the safety profile of maintenance olaparib; ?To evaluate the disease‐related symptoms and health‐related quality of life on maintenance olaparib as reported by the patients Timepoint(s) of evaluation of this end point: Every 8 weeks SECONDARY OUTCOME: Secondary end point(s): **Overall response rate and disease control rate; **Overall survival; **Toxicity and safety; **Quality of life Timepoint(s) of evaluation of this end point: during all the trial INCLUSION CRITERIA: Inclusion criteria for registration : 1.Provision of written informed consent to treatment and companion translational studies prior to any study specific procedures 2.Patients must be > 18 years of age. 3.Affiliation to an health insurance 4.Histological diagnosis of NSCLC 5.Advanced or metastatic disease (stage IIIB/IV) 6.Access to the original tumor biopsy or planning of a fresh tumor biopsy 7.Chemonaïve for NSCLC 8.Absence of EGFR‐sensitising mutation or ALK translocation 9.ECOG Performance Status of 0‐1 10.Fit to receive 4‐6 cycles of platinum‐based induction chemotherapy 11.Measurable lesions by RECIST v1.1 criteria, i.e. at least one lesion, not previously irradiated, that can be accurately measured at baseline as ? 10mm in the longest diameter (except lymph nodes that must have short axis ? 15mm) with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination and which is suitable for accurate repe