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

NCT02879617 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-054
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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 47 patients with advanced NSCLC and ECOG Performance Status 2 (PS2).

Conditions

Non-Small Cell Lung Cancer NSCLC

Keywords

PD-L1 (programmed cell death ligand 1)

Outcome Measures

Primary Outcomes (4)

• Overall Survival (OS)

  Median length of time from the start of treatment from start of treatment to death from any cause.

  Up to 30 months

• Overall Survival (OS12)

  Number of patients alive at 12 months post start of treatment.

  At 12 months

• Overall Survival (OS24)

  Number of patients alive at 24 months post start of treatment.

  At 24 months

• Treatment-related Adverse Events ≥ Grade 3

  Number of participants with ≥ Grade 3 adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 that are at least possibly related to study treatment.

  Up to 30 months

Secondary Outcomes (19)

• Progression-Free Survival (PFS)

  Up to 30 months

• Progression-Free Survival (PFS) at 12 Months

  At 12 months

• Progression-Free Survival (PFS) at 24 Months

  At 24 months

• Progression-Free Survival (PFS) by PD-L1 Expression at 12 Months

  At 12 months

• Progression-Free Survival (PFS) by PD-L1 Expression Status at 24 Months

  At 24 months

Study Arms (1)

durvalumab

EXPERIMENTAL

1500 mg of durvalumab will be administered intravenously (IV) on day 1 of every 28 day cycle.

Drug: durvalumab

Interventions

durvalumab DRUG

A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)

Also known as: MEDI4736

durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academic Thoracic Oncology Medical Investigators Consortium: lead
• AstraZeneca: collaborator

Study Sites (2)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Simmons Comprehensive Cancer Center - UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

durvalumab

Results Point of Contact

• Title: Barbara Stadterman, Regulatory Specialist Supervisor
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Liza Villaruz, MD

  University of Pittsburgh Cancer Institute, Department of Hematology Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Hematology Oncology

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 25, 2016
• Study Start: April 4, 2017
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: January 5, 2024
• Results First Posted: October 24, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data are available for 5 years after publication.
• Access Criteria: Proposals should be directed to villaruzl@upmc.edu

Locations

US (2)