Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]
Status:
Completed
Trial end date:
2021-01-15
Target enrollment:
Participant gender:
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.