AZD 2811 Monotherapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N3]

Inclusion Criteria

• •1. Provision of fully informed consent prior to any study specific procedures.
• •2. Patients must be ≥20 years of age.
• •3. Small cell lung cancer(SCLC) 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. Provision of tumor sample (from either archival or fresh biopsy)
• •5. Patients are 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.
• •6. ECOG performance status of 0-2
• •7. Patients must have a life expectancy ≥ 3 months from proposed first dose date.
• •8. Patients must have acceptable bone marrow, liver and renal function measured within 28days prior to administration of study treatment as defined below:
• •* Haemoglobin \> 9.0 g/dL
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• •* White blood cells (WBC) ≥ 3 x 109/L
• •* Platelet count ≥100 x 109/L
• •* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) except for subject with liver metastases for whom total bilirubin is ≤ 3 x ULN
• •* AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal(ULN) except for subject with liver metastases for whom AST(SGOT)/ALT(SGPT) is ≤ 5x ULN
• •* Alkaline phosphatase(ALP) ≤ 2.5 x institutional upper limit of normal(ULN) except for subject with liver metastases for whom ALP is ≤ 5 x ULN. ALP is not exclusionary if due to the presence of bone metastasis and liver function is otherwise considered adequate in the investigator's judgement.
• •* Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
• •Estimated creatinine clearance = (140-age \[years\]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72 a where F=0.85 for females and F=1 for males.
• •\- Albumin ≥ 33g/L
• •9. At least one measurable lesion that can be accurately assessed by imaging or physical examination.
• •10. Evidence of non-childbearing status for women of childbearing potential: A woman of childbearing potential must have a negative or urine pregnancy test at screening and confirmed prior to treatment on Cycle 1 Day 1
• •11. Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding. Fertile female patients of childbearing potential should use enhanced methods of contraception from the time of screening until 6 months after discontinuing study treatment. Acceptable methods of contraception include: combined oral or transdermal contraceptives, copper-banded intra-uterine devices and vasectomised partner. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse. Male patients should be asked to avoid unprotected sex with all sexual partners (by use of condoms) during the study, and for a washout period of 6 months after the last dose of study drug. Where a sexual partner of a male participant is a fertile female patient of childbearing potential, patients should avoid procreation for 6 months after completion of study drug treatment. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment