None listed
Conditions
Interventions
Drug : Patients will be randomized to receive a flat dose of pembrolizumab 200 mg IV to be administered either every 3 weeks or every 12 weeks once eligibility to the study is confirmed. Pembrolizumab
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years of age. 2. Have an ECOG Performance Status of = 2 at the time of study treatment initiation (see Appendix A). 3. Have pathologically confirmed diagnosis of NSCLC. Mixed SCLC histology is not allowed. 4. Must be eligible for treatment with pembrolizumab as standard of care (upto third line). 5. Patient has adequate bone marrow and organ function as defined by the following laboratory values: - Absolute neutrophil count (ANC) = 1.5 x 109/L - Platelets = 100 x 109/L - Hemoglobin = 9 g/dL - Serum creatinine = 1.5 x institution upper limit of normal (ULN) or estimated GFR (measured or calculated with Cockroft and Gault formula) > 45ml/min. - ALT and AST = 3 x ULN (ALT and AST = 5 x ULN is acceptable if liver metastases are present - Total serum bilirubin = 1.5x ULN. For patients with well documented Gilbert’s syndrome, total bilirubin = 3x ULN with direct bilirubin within normal range 6. Must have demonstrated complete response, partial response by RECIST or stable disease if >5% but less than 30% decrease from baseline total tumor burden (target lesions) to pembrolizumab at the time of randomization for study treatment. 7. Must have received at least 6 months of pembrolizumab treatment prior to start of protocol-assigned treatment 8. Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 9. Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion criteria
Exclusion criteria: 1. Receipt of anticancer chemotherapy within 6 months prior to randomization. 2. Disease progression to pembrolizumab as assessed by irRECIST 3. Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities. 4. Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy 5. Leptomeningeal involvement regardless of tumor response status 6. Tumor with mutation that is known to be sensitive to FDA- approved targeted therapy. 7. Patients who had pembrolizumab interrupted for more than 4 weeks for management of treatment-related adverse event. 8. Currently receiving or has received high-dose systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Patients who are on low-dose prednisone (10mg once daily or less) for at least 6 months for the management of other chronic disorders (e.g. COPD) is allowed. Steroids for endocrine replacement or receipt of short-course of steroids during the preceding 4 week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed. 9. Had major surgery within 14 days prior to starting protocol treatment 10. Active, clinically serious infections or other serious uncontrolled medical conditions. 11. Pregnant or nursing female participants. 12. Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug. 13. Unwilling or unable to follow protocol requirements.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To assess overall survival between the two treatment groups | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the 1year progression-free survival rate with pembrolizumab administered every 3 weeks compared to pembrolizumab administered every 12 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactAn Ju
Samsung Medical Center
Outcome results
None listed