1. Provision of informed consent prior to any study specific procedures
2. Small cell lung cancer that satisfies one or more of the following conditions:
1) BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other
HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B,
RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc.
3. Small cell lung cancer that has progressed during or after first-line therapy.
- The 1st line regimen must have contained platinum based regimen.
- Refractory to first-line chemotherapy or relapse within 6 months since the last dose
of first-line chemotherapy
- If the patient correspond to sensitive relapse (relapse more than 6 months since the
last dose of first-line chemotherapy), she/he should get second- line treatment.
4. Patients (male/female) must be > 20 years of age.
5. Patients must have normal organ and bone marrow function measured within 28 days
prior to administration of study treatment as defined below:
6. ECOG performance status 0-1 7. Patients must have a life expectancy ≥ 16 weeks 8.
Evidence of non-childbearing status for women of childbearing potential: negative
urine or serum pregnancy test within 28 days of study treatment, confirmed prior to
treatment on day 1 9. Patient is willing and able to comply with the protocol for the
duration of the study including undergoing treatment and scheduled visits and
examinations including follow up. 10. At least one lesion, not previously irradiated,
11. Provision of informed consent for genetic research.
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Participation in another clinical study with an investigational product during the
last 2 weeks (or a longer period depending on the defined characteristics of the
4. Any previous treatment with a PARP inhibitor, including olaparib.
5. More than two prior chemotherapy regimen for the treatment of small cell lung cancer.
Pazopanib maintenance or immune checkpoint inhibitor (CTLA4, PD-1 or PD-L1 monoclonal
antibody) is not considered as line of treatment.
6. Patients with second primary cancer
7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative
reasons), within 2 weeks from the last dose prior to study treatment (or a longer
period depending on the defined characteristics of the agents used). The patient can
receive a stable dose of bisphosphonates or denosumab for bone metastases, before and
during the study as long as these were started at least 4 weeks prior to treatment
with study drug.
8. Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole,
ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
9. Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia, caused by
previous cancer therapy.
10. Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or
family history of long QT syndrome.
11. Patients with myelodysplastic syndrome/acute myeloid leukaemia
12. Patients with symptomatic uncontrolled brain metastases.
13. Major surgery within 14 days of starting study treatment or patients not being
recovered from any effects of any major surgery
14. Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active, uncontrolled infection.
15. Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study
16. Breast feeding women
17. Immunocompromised patients,
18. Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of
transmitting the infection through blood or other body fluids.
19. Patients with a known hypersensitivity to olaparib or any of the excipients of the
20. Patients with uncontrolled seizures.