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. Acronym: PEMBRO-RT study

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis0 sitesNovember 19, 2015

ConditionsAdvanced non-small cell lung cancer MedDRA version: 19.0Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced non-small cell lung cancer
Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 19, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

Inclusion Criteria

•1\. Be willing and able to provide written informed consent/assent for the trial.
•2\. Be \= 18 years of age on day of signing informed consent.
•3\. Have measurable disease based on RECIST 1\.1\.
•4\. Must provide newly obtained tissue from a core or excisional biopsy of a tumor lesion and are willing to have a second biopsy performed form any non\-irradiated lesion after the radiation and immune\-modulating treatment.
•5\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
•6\. Stage IV NSCLC; treated with at least 1 regimen of chemotherapy.
•7\. Have at least 2 separate (metastatic) lesions of which one is amenable for irradiation with a size of \< 5 cm.
•8\. Demonstrate adequate organ function:
•Absolute neutrophil count (ANC) \=1,500 /mcL; Platelets \=100,000 / mcL; Hemoglobin \=9 g/dL or \=5\.6 mmol/L; Serum creatinine \=1\.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \=50 mL/min for subject with creatinine levels \> 1\.5 X institutional ULN; Serum total bilirubin \= 1\.5 X ULN OR Direct bilirubin \= ULN for subjects with total bilirubin levels \> 1\.5 ULN; AST (SGOT) and ALT (SGPT) \= 2\.5 X ULN OR \= 5 X ULN for subjects with liver metastases; International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) \=1\.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
•All screening labs should be performed within 10 days of treatment initiation.

Exclusion Criteria

•1\. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
•2\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•3\. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•4\. Has had prior chemotherapy or targeted small molecule therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•\- Note: Subjects with \= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•\- Note: If subjects received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•5\. Have had previous radical radiation to any tumor site within 6 months prior to study Day 1\.
•6\. Have known but untreated driver mutations of the EGFR gene or ALK translocation.
•7\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•8\. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least six weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.