NCT04361825

Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects

Phase Ⅱ, Single-arm Study of Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects [SUKSES-N4]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Se-Hoon Lee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, multi-center phase II study of durvalumab and AZD6738 combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line chemotherapy.

Detailed description

Subjects will receive durvalumab and AZD6738 combination therapy. The arm is composed of 45 subjects. Durvalumab 1500mg via IV administered for every 4weeks(fixed dosing for subjects \> 30 kg body weight) in Day 1 of each cycle and AZD 6738 240mg bid per os administered in each cycle days 15 and 28. One cycle is consisted of 28 days. Tumour evaluation using CT or MRI, RECIST 1.1, CEA, NSE and LDH will be conducted at screening (within 28days prior to first dose of Cycle1 Day1) and every 8weeks(±1week) for the first 56weeks relative to the start of combination therapy(Cycle1 Day1), and thereafter every 12weeks(±1week) until objective disease progression. Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Subjects may continue durvalumab and AZD6738 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 subjects 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 3months following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of durvalumab and AZD6738 treatment, will be collected. The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest, abdomen and pelvis. And CEA, NSE and LDH tests are also used for the evaluation. RECIST 1.1 scans will be analysed by the investigator on site. Subjects 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 subject's will.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500mg via IV administered for every 4weeks(fixed dosing for subjects \> 30 kg body weight) in Day 1 of each cycle and AZD 6738 240mg bid per os administered in each cycle days 1 and 7. One cycle is consisted of 28 days.

Timeline

• Start date: 2020-06-17
• Primary completion: 2023-10-25
• Completion: 2023-10-25
• First posted: 2020-04-24
• Last updated: 2024-01-03

Locations

2 sites across 1 country: South Korea