NCT03428607

Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]

Phase II, Single-arm Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, multi-center phase II study of AZD6738 and olaparib combination therapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line chemotherapy. Patients will receive AZD6738 and olaparib combination therapy. The arm is composed of 45 patients. AZD6738 160mg QD per os administered for 7 days and olaparib 300mg BID per os administered daily. One cycle is considered of 28 days. Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date, up to week 56, then every 12 weeks until objective disease progression (within a window of ± 7 days of the scheduled date). Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue AZD6738 and olaparib beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria. If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival. Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of AZD6738 and olaparib treatment, will be collected. The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest, abdomen and pelvis. RECIST 1.1 scans will be analysed by the investigator on site. Patients may also be requested to provide tumour samples from the primary or metastatic tumours on progression to understand resistance mechanisms. Sample provision is optional and depend on the patient's will.

Conditions

• SCLC

Interventions

Type	Name	Description
DRUG	AZD6738	AZD6738 160mg QD
DRUG	Olaparib	Olaparib 300mg BID

Timeline

• Start date: 2018-10-17
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2018-02-09
• Last updated: 2021-02-18

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study