Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

[Inclusion Criteria]

• Provision of informed consent prior to any study specific procedures
• Men and women aged at least 18 years
• Small cell lung cancer harboring RICTOR amplification
• Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
• Minimum life expectancy of 12 weeks
• Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
• At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
• No history of non-autologous bone marrow transplant.

Exclusion Criteria:

• Participation in another clinical study with an investigational product during the last 21 days.
• Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
• Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
• Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
• Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
• Any haemopoietic growth factors within 14 days prior to receiving study treatment.
• Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
• Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.