NCT04939662

Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects

Phase II, Single-arm Study of Olaparib and Bevacizumab Combination Therapy in Relapsed Small Cell Lung Cancer Subjects With DNA Damage Response and the Repair Pathway Alteration, ATM Deficiency, SLFN11 Positive, or POU2F3 Positive

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Se-Hoon Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, multi-centre phase II study of olaparib and bevacizumab combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line (systemic) therapy. Subjects will receive olaparib and bevacizumab combination therapy. The arm is composed of 28 subjects. Olaparib 300 mg bid per os every 12 hours administered each cycle day and bevacizumab 15 mg/kg via IV administered on Day 1 of every cycle for every 3 weeks. One cycle consists of 21 days.

Detailed description

Study design This study is a single arm, multi-centre phase II study of olaparib and bevacizumab combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line (systemic) therapy. Subjects will receive olaparib and bevacizumab combination therapy. The arm is composed of 28 subjects. Olaparib 300 mg bid per os every 12 hours administered each cycle day and bevacizumab 15 mg/kg via IV administered on Day 1 of every cycle for every 3 weeks. One cycle consists of 21 days. Tumour evaluation by RECIST v1.1 using CT or MRI scans of chest, abdomen, pelvis and brain (optional in case of brain metastases), CEA, NSE and LDH will be conducted at screening (within 28 days prior to first dose of Cycle1 Day1) and every 6 weeks (±1 week) for the first 42 weeks relative to the start of combination therapy (Cycle 1 Day 1), and thereafter every 9 weeks (±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 olaparib and bevacizumab 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 olaparib and bevacizumab 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

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Olaparib+Bevacizumab to SCLC patients	Olaparib 300 mg bid per os every 12 hours D1-21 administered in each cycle days. One cycle consists of 21 days. Bevacizumab 15 mg/kg via IV administered on Day1 of each cycle. One cycle is consisted of 21 days. The subject's body weight criterion is based on C1D1 (first dose date), and if more than 10% of BW is increased and decreased, the drug dose is changed to that BW.

Timeline

• Start date: 2021-06-11
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2021-06-25
• Last updated: 2024-01-02

Locations

1 site across 1 country: South Korea