NCT02492568

Pembrolizumab After SBRT Versus Pembrolizumab Alone in Advanced NSCLC

Randomized Phase II, 2-arm Study of Pembrolizumab After High Dose Radiation (SBRT) Versus Pembrolizumab Alone in Patients With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm compared to the pembrolizumab after SBRT arm at 12 weeks

Detailed description

The investigators hypothesize that in a significant subset of patients with recurrent NSCLC immunotherapy after SBRT will be superior to treatment with immunotherapy alone and that SBRT, given to a single metastatic site of the tumor, will augment the immune response to the tumor. Objectives: Disease Control Rate (DCR), defined as the percentage of patients having a complete response, partial response or stable disease at 12 weeks, PFS, defined as time from randomization to disease progression or death, OS, defined as time from randomization to death (of any cause). Toxicity.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	pembrolizumab
RADIATION	Stereotactic Body Radiation Therapy

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-07-08
• Last updated: 2020-08-17

Locations

1 site across 1 country: Netherlands