Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC
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|ClinicalTrials.gov Identifier: NCT02343952|
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Results First Posted : January 6, 2022
Last Update Posted : February 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Pembrolizumab||Phase 2|
OUTLINE: This is a multi-center study.
Eligible patients must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy, with restaging completed 28 days to 56 days post-chemoradiation. Patients with progressive disease will not be eligible for investigational treatment. Patients with stable disease/response will be eligible to register for investigational treatment of consolidation therapy to begin a minimum of 28 days and a maximum of 56 days from completion of chemoradiotherapy.
Pembrolizumab, 200 mg IV every 3 weeks (until progressive disease (PD), unacceptable toxicity, or after 12 months (52 weeks) of therapy with pembrolizumab.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absolute neutrophil count (ANC) ≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
- Serum creatinine OR measured or calculated creatinine clearance ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl)
- Serum total bilirubin ≤ 1.5 X institutional ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 institutional ULN
- Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 X institutional ULN
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT/INR/PTT is within therapeutic range of intended use of anticoagulants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||September 2022|
Experimental: Experimental Arm
Pembrolizumab -200 mg IV 3 weeks
Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Other Name: MK-3475
- Time to Death or Distant Metastasis [ Time Frame: From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months. ]Time to Death or Distant Metastasis is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. The Primary objective in the study was to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in subjects with inoperable or unresectable stage IIIA or IIIB NSCLC.
- Progression Free Survival [ Time Frame: From start of treatment until Progression based on RECIST 1.1 or death up to a maximum value of 47 months ]Progression Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves progression free survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). PFS has been estimated by Kaplan-Meier method.
- Overall Survival [ Time Frame: From the date of randomization up to a maximum value of 47 months or death. ]Overall Survival is defined as the time from the date of randomization until death due to any cause. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves Overall Survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). OS has been estimated by Kaplan-Meier method.
- Number of Participants Experiencing Grade 3-4 AE With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From the time of consent until 30 days after last dose of pembrolizumab up to a maximumof 18 months. ]One of the secondary objective in this study is to assess toxicity and tolerability of pembrolizumab consolidation therapy following concurrent chemoradiation in subjects with stage IIIA or IIIB NSCLC.
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): NCT02343952
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|United States, Indiana|
|Fort Wayne Oncology & Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46845|
|IU Health Goshen Hospital|
|Goshen, Indiana, United States, 46527|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|IU Health Central Indiana Cancer Centers|
|Indianapolis, Indiana, United States, 46219|
|Community Regional Cancer Care|
|Indianapolis, Indiana, United States, 49256|
|IU Health Arnett Cancer Center|
|Lafayette, Indiana, United States, 47904|
|Horizon Oncology Research, Inc.|
|Lafayette, Indiana, United States, 47905|
|IU Health at Ball Memorial Hospital|
|Muncie, Indiana, United States, 47303|
|Oncology Hematology Associates of SW Indiana|
|Newburgh, Indiana, United States, 47630|
|Northern Indiana Cancer Research Consortium|
|South Bend, Indiana, United States, 46601|
|United States, Kentucky|
|University of Louisville, James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|United States, Nebraska|
|Nebraska Cancer Specialists|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Nasser Hanna, M.D.||Hoosier Cancer Research Network|