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Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03559049
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Clovis Oncology, Inc.
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans, after induction therapy with carboplatin/pemetrexed/pembrolizumab (CPP) triplet therapy.

Condition or disease Intervention/treatment Phase
Stage IV Non-small Cell Lung Cancer Drug: Pembrolizumab Drug: Pemetrexed Drug: Carboplatin Drug: Rucaparib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multi-site Study of Rucaparib and Pembrolizumab Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer After Initial Therapy With Carboplatin, Pemetrexed, and Pembrolizumab
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Rucaparib and Pembrolizumab Maintenance

All patients will receive induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).

This will be followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).

Drug: Pembrolizumab
200mg IV every 21 days

Drug: Pemetrexed
500mg/m^2 IV every 21 days

Drug: Carboplatin
AUC 5 IV every 21 days

Drug: Rucaparib
600mg PO, BID days 1-21 of each 21 day cycle




Primary Outcome Measures :
  1. Median duration of time from start of treatment to time of progression [ Time Frame: Up to 5 years ]
    The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.


Secondary Outcome Measures :
  1. Median duration of time from the start of treatment until death [ Time Frame: Up to 5 years ]
    The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death.



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:

  • Have a life expectancy of at least 3 months
  • Have a histologically confirmed diagnosis of stage IV non-squamous NSCLC (non-small cell lung cancer) whose tumors do not have an epidermal sensitizing growth factor (EGFR) mutation or BRAF mutation or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1 and have at least one measurable lesion based on RECIST v1.1
  • Have a performance status of 0 or 1 on the ECOG Performance Scale (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
  • Demonstrate adequate organ function
  • Female subjects of childbearing potential should have a serum pregnancy within 14 days of enrollment and 72 hours prior to receiving the first dose of study medications.
  • Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the course of the study through 180 days after the last dose of study medications.
  • Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
  • Adequate tissue sample for correlative studies

Exclusion Criteria:

  • Received previous systemic therapy for stage IV NSCLC
  • Received radiation to the lungs >30Gy ≤6 months of enrollment
  • Received palliative radiation within 7 days of enrollment
  • Had prior treatment with any other anti-PD-1, PD-L1, or PD-L2 agent or an antibody targeting other immune-regulatory receptors or mechanisms
  • Received prior treatment with a PARP inhibitor
  • Has a known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment within the past 2 years
  • Subjects requiring daily corticosteroids >10mg of prednisone (or its equivalent) would be excluded from the study.
  • Has evidence of interstitial lung disease or a history of non-infectious pneumonitis that required oral or intravenous glucocorticoids to assist with management
  • Has an active infection requiring systemic therapy
  • 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 informed consent through 180 days after the last dose of trial treatment
  • Has a diagnosis of immunodeficiency (including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency (AIDS)-related illness) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Has known active Hepatitis B or Hepatitis C
  • Has received a live vaccine within 30 days of enrollment
  • A medical condition that requires daily systemic corticosteroids, greater than the equivalent of 10mg of prednisone

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): NCT03559049


Contacts
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Contact: Nithya Ramnath, MBBS 734-232-6789 nithyar@med.umich.edu

Locations
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United States, Michigan
The University of Michigan Rogel Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nithya Ramnath, MBBS    734-232-6789    nithyar@umich.edu   
Principal Investigator: Nithya Ramnath, MBBS         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Daniel Morgensztern, MD    314-747-7409      
Principal Investigator: Daniel Morgensztern, MD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Dwight Owen, MD         
Principal Investigator: Dwight Owen, MD         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Merck Sharp & Dohme Corp.
Clovis Oncology, Inc.
Investigators
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Principal Investigator: Nithya Ramnath, MBBS University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03559049     History of Changes
Other Study ID Numbers: UMCC 2018.033
HUM00142973 ( Other Identifier: University of Michigan )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rucaparib
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
Carboplatin
Pembrolizumab
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors