A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

Inclusion Criteria

• •Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
• •Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
• •Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
• •No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
• •Age 18 years or older.
• •Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnosfsky Performance Score (KPS) \>/= 70
• •Patients must have adequately recovered from any adverse events associated with prior immune-chemotherapy
• •Adequate organ and marrow function, including:
• •1. Haemoglobin \>/= 8.0 g/dL with no blood transfusion in the past 28 days.
• •2. Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L.
• •3. Platelet count \>/= 100 x 10\^9/L.
• •4. Total bilirubin \</= 1.5 x institutional upper limit of normal (ULN)
• •5. Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \</= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be \</= 5x ULN.
• •6. Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of \>/= 51 mL/min
• •Patients must have a life expectancy \>/= 16 weeks.
• •Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
• •a. Postmenopausal is defined as any one or more of the following: i. Age \>/= 60 years. ii. Age \< 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment.
• •iii. Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 60.
• •iv. Radiation-induced oophorectomy with last menses \>1 year ago v. Chemotherapy-induced menopause with \> 1 year interval since last menses. vi. Surgical sterilisation (bilateral oophorectomy or hysterectomy).
• •Men and women of childbearing potential must be willing to us two highly effective forms of contraception while on treatment and for at least 3 months after last dose of study drug.
• •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
• •Written informed consent
• •Other malignancy within the last 5 years except: early stage cutaneous melanoma, adequately treated non-melanomatous skin cancer, curatively treated in situ cervical cancer, ductal carcinoma in situ (DCIS), FIGO Grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for \>/= 5 years. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• •Absence of brain metastases is not required. Patients must not have symptomatic brain metastatic disease. The patient may be symptomatically controlled on a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
• •Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.