Pembrolizumab Every 12 Weeks Versus Every 3 Weeks in Treating Patients With Non-small Cell Lung Cancer
|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: NCT04032418|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2019
Last Update Posted : January 31, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Lung Non-Small Cell Carcinoma||Biological: Pembrolizumab||Phase 2|
I. To evaluate the 1-year progression-free survival rate with 200mg pembrolizumab administered every 3 weeks compared to 200mg pembrolizumab administered every 12 weeks.
I. To assess overall survival between the two treatment groups. II. To assess the serious adverse event profiles between the two treatment groups.
I. To evaluate circulating biomarkers of treatment response and resistance. II. To characterize fecal microbiotic profile and to correlate those results with tumor characteristics and antitumor immune responses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for at least 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Pembrolizumab 200mg every12 Weeks Versus Every 3 Weeks in NSCLC With Clinical Benefit to Pembrolizumab Monotherapy: Multicenter International Study|
|Actual Study Start Date :||August 13, 2020|
|Estimated Primary Completion Date :||September 3, 2023|
|Estimated Study Completion Date :||September 3, 2023|
Active Comparator: Arm I (200mg pembrolizumab 3 weeks)
Patients receive 200mg pembrolizumab IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (200mg pembrolizumab 12 weeks)
Patients receive 200mg pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
- 1-year progression-free survival (PFS) [ Time Frame: Baseline to 12 months ]Measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Overall survival [ Time Frame: Up to 12 months after treatment completion ]Defined as the number of months between Loading Phase enrollment and death from any cause. Analysis of overall survival between the two treatment groups will be carried forth using a log-rank test accounting for the stratification factors, including other known variables such as PD-L1 tumor proportion score, line of therapy, histology, mutation profile.
- Incidence of adverse events [ Time Frame: Up to 12 months ]Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be assessed through the evaluation of grade 3 or higher toxicities deemed possibly related to treatment. Both efficacy and toxicity rates will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed.
- Cox regression models in terms of treatment resistance [ Time Frame: Up to 12 months ]Circulating biomarkers of treatment response and resistance
- Length of time on treatment [ Time Frame: Up to 12 months ]Length of time on treatment as a time varying covariate will be carried out using Cox regression models.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at the time of study treatment initiation.
- Have pathologically confirmed diagnosis of non-small cell lung cancer (NSCLC). Mixed small cell lung cancer (SCLC) histology is not allowed.
- Must be eligible for treatment with pembrolizumab as standard of care (up to third line).
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
- Platelets >= 100 x 10^9/L.
- Hemoglobin >= 9 g/dL.
- Plasma creatinine =< 1.5 x institution upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) (measured or calculated with Cockcroft and Gault formula) > 45 ml/min.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (ALT and AST =< 5 x ULN is acceptable if liver metastases are present).
- Total plasma bilirubin =< 1.5 x ULN. For patients with well documented Gilbert?s syndrome, total bilirubin =< 3 x ULN with direct bilirubin within normal range.
- Must have demonstrated complete response, partial response by Response Evaluation Criteria in Solid Tumors (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.Patients with new brain metastasis isolated in the brain while on pembrolizumab monotherapy will be eligible as long as extracranial disease control fulfills the criteria otherwise (i.e. this will not be considered as disease progression for the purpose of this study).
- Must have received at least 6 months of pembrolizumab monotherapy treatment (but no more than 15 months total duration, including treatment in combination with chemotherapy prior to maintenance phase) prior to start of protocol-assigned treatment.
- 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.
- 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.
- Receipt of anticancer chemotherapy, other than pembrolizumab, within 6 months prior to randomization.
- Disease progression to pembrolizumab as assessed by immune related (ir)RECIST.
- Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities.
- 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.
- Leptomeningeal involvement regardless of tumor response status.
- Tumor with mutation that is known to be sensitive to Food and Drug Administration (FDA)- approved targeted therapy.
- Patients who had pembrolizumab interrupted for more than 4 weeks for management of treatment-related adverse event.
- 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 (10 mg once daily or less) for at least 6 months for the management of other chronic disorders (e.g. chronic obstructive pulmonary disease [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.
- Had major surgery within 14 days prior to starting protocol treatment.
- Active, clinically serious infections or other serious uncontrolled medical conditions.
- Pregnant or nursing female participants.
- Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug.
- Unwilling or unable to follow protocol requirements.
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): NCT04032418
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Grace K Dy||Roswell Park Cancer Institute|
|Responsible Party:||Roswell Park Cancer Institute|
|Other Study ID Numbers:||
NCI-2019-04326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
i 82319 ( Other Identifier: Roswell Park Cancer Institute )
|First Posted:||July 25, 2019 Key Record Dates|
|Last Update Posted:||January 31, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Immunological