Exclusion criteria | |
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Step 1 | |
1 Patients involved in GUIDE2REPAIR study planning and/or conduct. | |
2 Patients with EGFR, BRAF, ROS1 mutation or ALK rearrangement with lung small cell cancer and are not eligible. | |
3 Patient eligible for another study of AstraZeneca Participation in another clinical study with an investigational product within 2 months prior to first olaparib administration. | |
4 Administration of any anticancer therapy ≤21 days prior to the first dose of olaparib or 5 times its half-life, whichever smaller. | |
5 Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapya. | |
6 Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatmentb. | |
7 Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drugc. | |
8 Major surgical procedure within 28 days prior to inclusion and patients must have recovered from any effects of any major surgery IP. | |
9 Patients unable to swallow orally administered medication and patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs. | |
10 History of allogenic organ, bone marrow or double umbilical cord blood transplantationd. | |
11 Active or prior documented autoimmune or inflammatory disorders. | |
12 Uncontrolled intercurrent illness or patient considered at medical risk due to a serious, uncontrolled medical disorder or psychiatric illness/social situation that would limit study compliance, substantially increase risk of incurring AEs or compromise patient’s ability to give written informed consent. | |
13 Currently taking medications with known risk of prolonging the QT interval or inducing “torsades de pointes”. | |
14 Concomitant use of known strong or moderate CYP3A inducers. | |
15 Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or patients with congenital long QT syndrome. | |
16 Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML. | |
17 History of another primary malignancye. | |
18 Patient with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. | |
19 History of active primary immunodeficiency and immunocompromised patients. | |
20 Active infection. | |
21 Current or prior use of immunosuppressive medication within 14 days before inclusion. | |
22 Administration of live attenuated vaccine within 30 days prior to the first dose of IP. | |
23 Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential not willing to employ effective birth control. | |
24 Known allergy or hypersensitivity to any of the study drugs or excipients. | |
25 Prior treatment with any PARP inhibitor including olaparib or immunotherapy. | |
Step 2 | |
Patients should not enter the study if any of the exclusion criteria from STEP 1 and the following criteria for STEP 2 are fulfilled: 26 Patient with progression observed on CT scan performed after 6 weeks of olaparib (STEP 1). |