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

• vistusertib (AZD2014) (Drug): vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.

Primary outcomes

• Objective reponse rate (ORR) by RECIST 1.1 [Up to 20 months]: Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1

Secondary outcomes

• Duration of response [Up to 20 months]: Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
• Disease control rate [at 12 weeks]: Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
• Overall survival (OS) [Up to 20 months]: Kaplan-Meier method
• Progression-free survival (PFS) [Up to 20 months]: Kaplan-Meier method
• Number of participants with Adverse Events as Assessed by CTCAE v4.03 [Up to 20 months]: CTCAE v4.03

Sex: All, ages: 18 Years to any

\[Inclusion Criteria\]

* 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.