Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC

NCT02343952 | Completed Phase 2 Results DMC

• 1 other identifier: HCRN LUN14-179
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 15

Brief Summary

This is an open label, multi-institutional, single arm phase II trial of consolidation therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or blinding is involved.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Pembrolizumab; MK-3475

Outcome Measures

Primary Outcomes (1)

• Time to Death or Distant Metastasis

  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.

  From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months.

Secondary Outcomes (3)

• Progression Free Survival

  From start of treatment until Progression based on RECIST 1.1 or death up to a maximum value of 47 months

• Overall Survival

  From the date of randomization up to a maximum value of 47 months or death.

• Number of Participants Experiencing Grade 3-4 AE With Adverse Events as a Measure of Safety and Tolerability

  From the time of consent until 30 days after last dose of pembrolizumab up to a maximumof 18 months.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Pembrolizumab -200 mg IV 3 weeks

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.

Also known as: MK-3475

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Histological or cytological evidence of NSCLC
• Must have unresectable or inoperable stage IIIA or IIIB disease. Patients are considered unresectable or inoperable based on the judgment of the treating physician
• 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
• Must have stable disease or disease response as evidenced on CT evaluation a minimum of 28 days and a maximum of 56 days following the completion of chemoradiation
• 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 of childbearing potential 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
• Age ≥ 18 years at the time of consent
• Written informed consent and HIPAA authorization for release of personal health information

You may not qualify if:

• 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. Subjects must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration for protocol therapy to exclude brain metastases if symptomatic or without prior brain imaging
• Treatment with any investigational agent within 28 days prior to registration for protocol therapy
• Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
• Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy
• Presence of metastatic disease (stage IV NSCLC) is not allowed. Subjects must be evaluated with a PET scan within 28 days prior to registration for protocol therapy to exclude metastatic disease
• No active second cancers
• 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. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
• Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
• Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of first dose of study drug
• History of psychiatric illness or social situations that would limit compliance with study requirements
• Clinically active infection as judged by the treating investigator (≥ Grade 2 by CTCAE v4) including known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
• 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

Sponsors & Collaborators

• Nasser Hanna, M.D.: lead
• Merck Sharp & Dohme LLC: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (15)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Fort Wayne Oncology & Hematology, Inc.

Fort Wayne, Indiana, 46845, United States

Location

IU Health Goshen Hospital

Goshen, Indiana, 46527, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

IU Health Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Community Regional Cancer Care

Indianapolis, Indiana, 49256, United States

Location

IU Health Arnett Cancer Center

Lafayette, Indiana, 47904, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

IU Health at Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

Oncology Hematology Associates of SW Indiana

Newburgh, Indiana, 47630, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Links

• Hoosier Cancer Research Network Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Annesha Majumdar
• Organization: Hoosier Cancer Research Network

amajumdar@hoosiercancer.org

3179212050

Study Officials

• Nasser Hanna, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

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: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 22, 2015
• Study Start: March 9, 2015
• Primary Completion: August 10, 2020
• Study Completion: January 1, 2021
• Last Updated: September 13, 2023
• Results First Posted: January 6, 2022

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)