Pembrolizumab After SBRT Versus Pembrolizumab Alone in Advanced NSCLC (PEMBRO-RT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02492568|
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : August 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: pembrolizumab Radiation: Stereotactic Body Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: SBRT + Pembrolizumab
Stereotactic Body Radiation Therapy (SBRT) followed by pembrolizumab treatment within 7 days of completion. SBRT: 3 x 8 Gy, given 1-2 weeks prior to start of pembrolizumab. Dose of pembrolizumab is 200 mg, every 3 weeks. Patients can continue the pembrolizumab treatment for maximal 2 years.
Other Name: MK3475
Radiation: Stereotactic Body Radiation Therapy
Other Name: SBRT
Active Comparator: Pembrolizumab alone
Dose of pembrolizumab is 200 mg, every 3 weeks.Patients can continue the pembrolizumab treatment for maximal 2 years.
Other Name: MK3475
- Overall Response Rate [ Time Frame: at 12 weeks ]Patients having a partial response or complete response are considered successes, while all other situations are considered failures.
- The percentage of patients having a complete response, partial response or stable disease at 12 weeks [ Time Frame: at 12 weeks ]
- Time from randomization to disease progression or death [ Time Frame: Until progression, median 5 months ]
- Time from randomization to death (of any cause). [ Time Frame: every 12 weeks, median 5 months ]
- Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0 [ Time Frame: up to 30 days after end of treatment ]Toxicity will be analyzed in patients who have received at least one administration of pembrolizumab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492568
|Antoni van Leeuwenhoek (NKI-AVL)|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Principal Investigator:||Paul Baas, MD, PhD||Antoni van Leeuwenhoek|
|Principal Investigator:||Willemijn Theelen, MD||Antoni van Leeuwenhoek|