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Phase II Trial of Continuation Therapy in Advanced NSCLC

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ClinicalTrials.gov Identifier: NCT03083808
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Big Ten Cancer Research Consortium
Information provided by (Responsible Party):
Greg Durm, MD, Big Ten Cancer Research Consortium

Brief Summary:
This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Pembrolizumab Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m2 IV D1 and D8 every three weeks, docetaxel 75mg/m2 IV D1 every three weeks, or pemetrexed 500mg/m2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.

Administration Sequence: First Sequence

- Pembrolizumab 200mg IV on Day 1 (cycle = 21 days)

Administration Sequence: Second Sequence

  • Gemcitabine 1000mg/m^2 IV on Days 1,8 (cycle = 21 days)
  • Docetaxel 75mg/^2 IV on Days 1,8 (cycle = 21 days)
  • Pemetrexed 500mg/m^2 IV on Day 1 (cycle -= 21 days)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Chemotherapy Plus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With PD-1 or PD-L1 Inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab 200mg IV every 21 days
Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.
Drug: Pembrolizumab

Pembrolizumab 200mg IV every 21 days

Physician's choice chemotherapy with one of the following every 21 days:

  • Docetaxel 75mg/m2 IV
  • Pemetrexed 500mg/m2 IV (non-squamous only)
  • Gemcitabine 1000mg/m2 IV on days 1 and 8
Other Names:
  • Keytruda®
  • MK-3475




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 3 months ]
    A measurement from the date of treatment start until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs


Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: 3 months ]
    any subject with stable disease for ≥ 3 months, partial response, or complete response assessed via RECISIT 1.1 and irRECIST

  2. Objective Response Rate (ORR) [ Time Frame: 1 year ]
    The ORR is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence

  3. Overall Survival (OS) [ Time Frame: 2 years ]
    Overall survival is defined by the date of treatment start to date of death from any cause

  4. Assess Toxicity [ Time Frame: 2 years ]
    Toxicity will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following applicable inclusion criteria to participate in this study:

  • Written informed consent and HIPAA authorization for release of protected health information.
  • Age ≥ 18 years at the time of consent.
  • Histological or cytological evidence of stage IV NSCLC (any histology)
  • Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including pembrolizumab) as their most recent therapy and must have had at least a 3-month PFS on this therapy.
  • Subjects must be enrolled on the trial within 6 weeks of their last infusion of PD-1 or PD-L1 inhibitor therapy.
  • Subjects whose tumors harbor a mutation in EGFR exon 19 or 21 or have gene rearrangements in ALK or ROS1 must have already been treated with standard targeted therapies. NOTE: Subjects must also have progressed on or after platinum-containing combination chemotherapy.
  • ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy.
  • Must be fit enough to receive next-line chemotherapy (either gemcitabine, docetaxel, or pemetrexed [non-squamous only]) according to the discretion of the treating physician.
  • Adequate laboratory values obtained within 28 days prior to registration for protocol therapy.
  • Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to study registration and/or within 72 hours of first dose of study drugs. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Women of childbearing potential must be willing to use two methods of contraception or abstain from heterosexual activity from the point of registration through 120 days after the last dose of study drug.
  • Male subjects capable of fathering a child must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Active central nervous system (CNS) metastases. NOTE: Subjects who are symptomatic or have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.
  • Treatment with any investigational agent within 28 days prior to registration for protocol therapy with the exception of PD-1 or PD-L1 inhibitors.
  • No active second cancers with the exception of localized non-melanoma skin cancer, in-situ cervical or in-situ bladder cancer.
  • Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
  • History of (non-infectious) pneumonitis requiring treatment with corticosteroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • History of an immune-related toxicity requiring treatment with corticosteroids during prior PD-1/ PD-L1 inhibitor treatment.
  • Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of study registration.
  • History of psychiatric illness or social situations that would limit compliance with study requirements.
  • Clinically active infection (≥ Grade 2) as judged by the site investigator.
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. NOTE: HIV, HBV or HCV testing is not required.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator.
  • Known history of active TB (Bacillus Tuberculosis).
  • History of hypersensitivity to pembrolizumab, docetaxel, gemcitabine, pemetrexed or any of their excipients.
  • Has received a live vaccine within 30 days prior to planned start of study therapy.

Information from the National Library of Medicine

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): NCT03083808


Contacts
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Contact: Donna Sullivan 317.634.5842 ext 40 dsullivan@hoosiercancer.org
Contact: Greg Durm, M.D. 317.656.4260 gdurm@iu.edu

Locations
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United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Margaret Gavor    312-355-4200    mgavor2@uic.edu   
Principal Investigator: Lawrence Feldman, MD         
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Greg Durm, MD    317-656-4260    gdurm@iu.edu   
Contact: Ashley Hudson    317-278-5638    ashnhuds@iu.edu   
United States, Iowa
University of Iowa Hospital Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sarah Heady    319-384-4241    sarah-heady@uiowa.edu   
Principal Investigator: Muhammad Furgan, MD         
United States, Minnesota
University of Minnesota Medcical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Naomi Fujioka, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: UWCCC Lung Cancer ClinicalTrials Office    608-263-3078    lunggroup@uwcarbone.wisc.edu   
Principal Investigator: Ticiana Leal, MD         
Sponsors and Collaborators
Greg Durm, MD
Merck Sharp & Dohme Corp.
Big Ten Cancer Research Consortium
Investigators
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Study Chair: Greg Durm, M.D. Big Ten Cancer Research Consortium

Additional Information:
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Responsible Party: Greg Durm, MD, Sponsor-Investigator, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier: NCT03083808     History of Changes
Other Study ID Numbers: BTCRC-LUN15-029
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Greg Durm, MD, Big Ten Cancer Research Consortium:
PD-1
PD-L1 Inhibitor
Pembrolizumab
Docetaxel
Pemetrexed
Gemcitabine

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Pemetrexed
Docetaxel
Pembrolizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Immunological
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors