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Pembrolizumab in Combination With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation and ALK Positive NSCLC (Non-Small Cell Lung Cancer) With Progressive Disease Following Prior Tyrosine Kinase Inhibitors (TKIs)

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ClinicalTrials.gov Identifier: NCT03242915
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following prior TKIs (tyrosine kinase inhibitors).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multi-center Study of Pembrolizumab in Combination With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation and ALK Positive NSCLC (Non-Small Cell Lung Cancer) With Progressive Disease Following Prior Tyrosine Kinase Inhibitors (TKIs)
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab/Carboplatin/Pemetrexed
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks
Drug: Pembrolizumab
200mg IV every 3 weeks

Drug: Carboplatin
AUC 5 IV every 3 weeks

Drug: Pemetrexed
500 mg/m^2 IV every 3 weeks




Primary Outcome Measures :
  1. The number of patients that respond to treatment [ Time Frame: 12 months ]
    The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).


Secondary Outcome Measures :
  1. Progression free survival (PFS) time [ Time Frame: 12 months ]
    PFS is defined as the duration of time from registration to time of progression. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

  2. Overall survival (OS) time [ Time Frame: 12 months ]
    Overall survival is defined as the time from registration to time of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.



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:

  • Exon 19 deletion or Exon 21 L858R or L861Q or exon 18 G719X or S7681 EGFR mutation positive NSCLC patients, or ALK rearranged NSCLC patients previously treated with a tyrosine kinase inhibitor with progressive and measurable disease.
  • Tumor tissue for PD-L1 assessment should be available unless PD-L1 assessment results are already available.
  • Patients should not have received any systemic chemotherapy for advanced NSCLC. Patients who have received neoadjuvant, adjuvant or as part of concurrent chemotherapy and radiation are eligible if they received the chemotherapy 12 months or more before the start of study therapy.
  • ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)
  • Patients should have recovered to ≤ grade 1 from clinically meaningful (example alopecia is not considered clinically meaningful) adverse events related to prior treatments.
  • Patients should be willing and able to provide written informed consent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Demonstrate adequate organ function
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 1 week of enrollment.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception
  • Male subjects of child bearing potential must agree to use an adequate method of contraception

Exclusion Criteria:

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. If the half-life of the drug is known then starting therapy 5 half-lives after the end of the last therapy is acceptable.
  • Has a diagnosis of immunodeficiency. Patient should not be of any immunosuppressive therapy or steroids > prednisone 10mg/day or its equivalent on the day of the start of therapy.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab, carboplatin or pemetrexed or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) 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.
  • Has had targeted small molecule therapy, or palliative radiation therapy within 1 week 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.
  • Has a known additional malignancy that is progressing or requires active treatment or the treating physician believes will require therapy within 1 year.
  • Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has known history of non-infectious pneumonitis that required steroids or has current pneumonitis. Has known history of interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a 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 treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is 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.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B or Hepatitis C
  • Has received a live vaccine within 30 days of 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): NCT03242915


Contacts
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Contact: Shirish M Gadgeel, M.D. 7346476883 sgadgeel@med.umich.edu

Locations
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United States, Illinois
Rush Universtiy Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Jo Fidler, MD         
Principal Investigator: Mary Jo Fidler, MD         
United States, Michigan
The University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shirish M Gadgeel, M.D.    734-647-6883    sgadgeel@med.umich.edu   
Principal Investigator: Shirish M Gadgeel, M.D.         
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Misako Nagaska, MD         
Principal Investigator: Misako Nagaska, MD         
United States, New York
Montefiore Cancer Center Recruiting
Bronx, New York, United States, 10467
Contact: Balazs Halmos, MD         
Principal Investigator: Balazs Halmos, MD         
United States, Tennessee
Sarah Cannon Recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa Johnson, MD         
Principal Investigator: Melissa Johnson, MD         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Shirish M Gadgeel, M.D. University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03242915     History of Changes
Other Study ID Numbers: UMCC 2017.057
HUM00129169 ( Other Identifier: University of Michigan )
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

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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.: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Disease Progression
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes
Carboplatin
Pembrolizumab
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors