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A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients

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. Identifier: NCT02879617
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
Liza Villaruz, University of Pittsburgh

Brief Summary:
This is a single-arm phase II clinical trial evaluating the safety and efficacy of the PD-L1 inhibitor durvalumab as first-line therapy in 50 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).

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

Detailed Description:
Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous (IV) administration. Durvalumab will be administered at 1500 mg (fixed dose) every 4 weeks until disease progression, death, unacceptable toxicity or withdrawal of consent for a maximum of 12 months of therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Evaluating the Safety and Efficacy of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : June 4, 2022
Actual Study Completion Date : June 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: durvalumab
1500 mg of durvalumab will be administered intravenously (IV) on day 1 of every 28 day cycle.
Drug: durvalumab
A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)
Other Name: MEDI4736

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 42 months ]
    Median length of time from the start of treatment that patients are still alive.

  2. Treatment-related Adverse Events [ Time Frame: Up to 33 months ]
    Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 that are possibly, probably or definitely related to study treatment.

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 42 months ]
    The duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.0 Progressive Disease (PD) for target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

  2. Overall Response Rate (ORR) [ Time Frame: Up to 42 months ]
    Proportion of patients who achieve either a Complete Response or Partial Response to study treatment. Per RECIST v1.0, for target lesions: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions: Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). If tumor markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response. Non-CR/Non-PD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

  3. Health Related Quality of Life (HRQL) - FACT-L questionnaire [ Time Frame: At baseline, the end of each treatment cycle, and at the end of therapy; Up to 30 months ]
    Patient self-administered questionnaire that measures the respondents' health state over the last 7 days.Scoring: Five-point scale: 0 (not at all) to 4 (very much) Note: Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.

Information from the National Library of Medicine

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.

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

Inclusion Criteria:

  • Written informed consent
  • Patients must have histologically or cytologically confirmed Stage IIIB or IV (American Joint Committee on Cancer, 7th edition; AJCC 7) non-small cell lung cancer.
  • Patients must have measurable disease.
  • Patients must have not have received any prior therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) for the treatment of stage IV NSCLC.
  • Age ≥ 18 years at time of study entry.
  • ECOG performance status of 2.
  • Life expectancy of greater than 12 weeks.
  • Tissue available (archived or fresh tumor biopsy) for the PD-L1 assay.
  • Patients must have normal organ and marrow function as defined below:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (> 1500 per mm^3)
    • Hemoglobin ≥ 9.0 g/dL
    • Platelet count ≥ 100 x 10^9/L (>100,000 per mm^3)
    • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present, in which case it must be ≤ 5x ULN Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula
  • Female subjects must either be of non-reproductive potential OR must have a negative serum pregnancy test upon study entry.
  • The effects of durvalumab on the developing human fetus are unknown. For this reason and because immunomodulatory agents are potentially teratogenic, sexually active women of child-bearing potential and men must agree to use adequate contraception (2 methods of effective contraception from screening) from screening, for the duration of study participation, and for at least 90 days following the last infusion of durvalumab.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study; previous enrollment in the present study.
  • Participation in another clinical study with an investigational product for cancer during the last 12 months.
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab.
  • Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids in excess of prednisone 10 mg/d or equivalent.
  • Sensitizing mutations in EGFR or rearrangements in ALK or ROS1.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab.
  • Mean QT interval corrected for heart rate (QTc) ≥ 470 ms.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids . Patients may be on systemic corticosteroids provided the dose does not exceed prednisone 10 mg/d or equivalent for 1 week prior to study drug administration.
  • Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of primary immunodeficiency.
  • History of allogeneic organ transplant.
  • Uncontrolled intercurrent illness.
  • Known history of previous clinical diagnosis of tuberculosis.
  • History of leptomeningeal carcinomatosis.
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
  • Subjects with uncontrolled seizures.
  • Pregnant women; breastfeeding should be discontinued.
  • Prior history of radiation pneumonitis.

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 identifier (NCT number): NCT02879617

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United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Simmons Comprehensive Cancer Center - UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Academic Thoracic Oncology Medical Investigators Consortium
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Principal Investigator: Liza Villaruz, MD University of Pittsburgh Cancer Institute, Department of Hematology Oncology
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Responsible Party: Liza Villaruz, Assistant Professor of Medicine, Division of Hematology Oncology, University of Pittsburgh Identifier: NCT02879617    
Other Study ID Numbers: 16-054
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
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
Keywords provided by Liza Villaruz, University of Pittsburgh:
PD-L1 (programmed cell death ligand 1)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents