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Trial record 1 of 2 for:    Atezolizumab and daratumumab
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A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (DARZALEX)

This study is currently recruiting participants.
Verified November 2017 by Janssen Research & Development, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03023423
First Posted: January 18, 2017
Last Update Posted: November 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: Atezolizumab Drug: Daratumumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: From randomization to end of study (an expected average of 3 years) ]
    ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=)30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Screening (28 days ) to end of treatment (30 days after the last dose) ]
  • Duration of Response (DoR) [ Time Frame: From randomization to the date of first documented evidence of Progressive Disease [PD] (an expected average of 3 years ]
    Duration of Response is defined as the duration from the date of the initial documentation of a response to the date of the first objectively documented evidence of progressive disease or death (At least 20% increase in the sum of the longest diameters of index lesions), whichever status is recorded first.

  • Percentage of Participants who Achieve Disease Control (CR, PR, or SD with duration of at least 16 weeks) Clinical Benefit Rate (CBR) [ Time Frame: From randomization to end of study (an expected average of 3 years) ]
    Clinical Benefit Rate is defined as the proportion of participants who achieve disease control (complete response [CR], Disappearance of all lesions; partial response [PR], greater than or equal to (>=) 30% decrease in the sum of the diameters of all index lesions; or stable disease [SD], less than (<) 30% decrease in sum of longest diameters of all index lesions with duration of at least 16 weeks).

  • Progression-Free Survival (PFS) [ Time Frame: From randomization to the date of first documented evidence of PD (an expected average of 3 years) ]
    PFS is defined as the duration from the date of randomization to the date of objectively documented progression or death due to any cause, whichever status is recorded first.

  • Overall Survival (OS) [ Time Frame: From randomization to the date of first documented evidence of PD (an expected average of 3 years) ]
    Overall Survival is defined as the duration from the date of randomization to the date of death due to any cause.

  • Maximum Observed Analyte Concentration (Cmax) of Daratumumab [ Time Frame: Predose and end of infusion Cycle 1 Day 1(C1D1), Predose-C2D1, C3D1, C3D15, end of infusion-C3D15; predose and end of infusion-C4D1, predose and end of infusion-C8D1; predose-C12D1, C16D1 up to end of treatment (30 days after the last dose) ]
    Maximum observed analyte concentration of daratumumab will be assessed.

  • Maximum Observed Analyte Concentration (Cmax) of Atezolizumab [ Time Frame: Predose and end of infusion-C1D1, end of infusion - C1D2, predose - C2D1, C3D1 ; pre-dose and end of infusion-C4D1, pre-dose and end of infusion-C8D1; predose-C12D1, C16D1 up to end of treatment (30 days after the last dose) ]
    Maximum observed analyte concentration of atezolizumab will be assessed.

  • Minimum Observed Analyte Concentration (Cmin) of Daratumumab [ Time Frame: Predose and end of infusion Cycle 1 Day 1(C1D1), Predose-C2D1, C3D1, C3D15, end of infusion-C3D15; predose and end of infusion-C4D1, predose and end of infusion-C8 D1; predose-C12D1, C16D1 up to end of treatment (30 days after the last dose) ]
    Minimum observed analyte concentration of daratumumab will be assessed.

  • Minimum Observed Analyte Concentration (Cmin) of Atezolizumab [ Time Frame: Predose and end of infusion-C1D1, end of infusion - C1D2, predose - C2D1, C3D1 ; pre-dose and end of infusion-C4D1, pre-dose and end of infusion-C8D1; predose-C12D1, C16D1 up to end of treatment (30 days after the last dose) ]
    Minimum observed analyte concentration of atezolizumab will be assessed.

  • Anti-Daratumumab Antibodies Concentration [ Time Frame: predose - C1D1, C2D1, C8D1, C12D1, C16D1 up to end of treatment (30 days after the last dose) ]
  • Anti-Atezolizumab Antibodies Concentration [ Time Frame: predose - C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1 up to end of treatment (30 days after the last dose) ]

Estimated Enrollment: 96
Actual Study Start Date: December 23, 2016
Estimated Study Completion Date: October 16, 2020
Estimated Primary Completion Date: July 25, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm A: Atezolizumab
Participants in Treatment Arm A will receive Atezolizumab 1,200 milligram (mg) intravenously (IV) on Day 1 of every 21-day cycle. Participants with confirmed disease progression based on RECIST 1.1 may cross over to Arm B and receive daratumumab and atezolizumab, provided crossover eligibility criteria are met.
Drug: Atezolizumab
Participants will receive atezolizumab 1200 mg intravenously.
Experimental: Treatment Arm B: Atezolizumab and Daratumumab
Participants will receive daratumumab 16 milligram per kilogram [mg/kg] (Safety Run-in and Treatment Arm B) Intravenously (IV) weekly for 3 cycles (Day 1, 8 and 15), and Day 1 of every 21-day cycle thereafter. Atezolizumab will be administered at 1200 mg IV on Day 2 of Cycle 1 and on Day 1 of every 21-day cycle thereafter. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
Drug: Atezolizumab
Participants will receive atezolizumab 1200 mg intravenously.
Drug: Daratumumab
Participants will receive daratumumab 16 mg/kg intravenously.
Other Name: JNJ-54767414

Detailed Description:
This randomized (study medication assigned to participants by chance), multicenter study will provide study treatment (atezolizumab alone or atezolizumab+daratumumab) to participants with previously treated advanced or metastatic NSCLC to assess the anti-tumor activity and safety. Participants who receive atezolizumab treatment with confirmed disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be eligible to crossover to treatment (atezolizumab + daratumumab) if they meet crossover eligibility criteria. It is expected that the vast majority of approximately 96 participants will enroll in the study, including 6 participants in a safety run in phase. Data Monitoring Committee (DMC) will review ongoing data, and may formulate recommendations on study conduct, including expansion of enrollment of some PD-L1 subgroups, resulting in greater than 96 participants. The participants in the safety run in phase will be administered the combination of daratumumab and atezolizumab to determine the safety and tolerability that will be evaluated by the Safety Evaluation Team (SET) for dose limiting toxicity before the random assignment of participants in a 1:1 ratio in 2 treatment arms. The study consists of 3 phases: Screening Phase (up to 28 days), Treatment Phase and Post-Treatment Follow-up Phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study [the study end is approximately 6 to 12 months after that last participant is enrolled]. Participants will undergo tumor assessments (RECIST 1.1), immunogenicity, pharmacokinetics, biomarkers and safety evaluations (adverse events, laboratory tests, electrocardiogram [ECGs], vital sign measurements, physical examinations, Eastern Cooperative Oncology Group [ECOG] performance status score) over the time.
  Eligibility

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.


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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIb or greater)
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Known PD-L1 tumor status as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained at Screening
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration

Inclusion Criteria for Crossover:

  • Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1
  • Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over. If not clinically feasible, discussion with Sponsor is required
  • The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over

Exclusion Criteria:

  • Received any of the following prescribed medications or therapies in the past:

    1. Anti-cluster of differentiation(CD)38 therapy, including daratumumab
    2. CD137 agonists, immune checkpoint inhibitors including but not limited to CTLA-4, anti-PD-1, and anti-PD-L1 therapies
  • Known to be seropositive for human immunodeficiency virus (HIV)
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Active hepatitis B, defined by a positive test for hepatitis B surface antigen [HBsAg] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc], regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection

Exclusion Criteria for Crossover:

  • Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
  • Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug after crossing over
  Contacts and Locations
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): NCT03023423


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Center Withdrawn
Chandler, Arizona, United States, 85224
Mayo Clinic Scottsdale Withdrawn
Scottsdale, Arizona, United States, 85259
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Cancer Care Associates Medical Group, Inc. Withdrawn
Redondo Beach, California, United States, 90277
Innovative Clinical Research, Inc. Not yet recruiting
Whittier, California, United States, 90606
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19713
United States, Florida
University of Miami Health System Sylvester at Deerfield Bea Recruiting
Deerfield Beach, Florida, United States, 33442
Michael and Dianne Bienes Cancer Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Mayo Clinic Cancer Clinical Studies Unit Withdrawn
Jacksonville, Florida, United States, 32224
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Florida Specialist and Cancer Institute Withdrawn
Sarasota, Florida, United States, 34232
H. Lee Moffitt Cancer Center Withdrawn
Tampa, Florida, United States, 33612-9416
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
University Cancer & Blood Center, LLC Recruiting
Athens, Georgia, United States, 30607
Piedmont Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30318
Winship Cancer Institute Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Louisville - James Graham Brown Cancer Center Withdrawn
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit Recruiting
New Orleans, Louisiana, United States, 70121-2429
Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit Withdrawn
New Orleans, Louisiana, United States, 70121-2429
United States, Maryland
Rcca Md, Llc Not yet recruiting
Bethesda, Maryland, United States, 20817
United States, New Jersey
Hematology-Oncology Associates of Northern NJ Withdrawn
Morristown, New Jersey, United States, 07960
United States, North Carolina
University of North Carolina - NC Cancer Hospital Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Oklahoma
Mercy Physicians of Oklahoma Not yet recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Chattanooga, Tennessee, United States, 37404
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Tennessee Cancer Specialists Withdrawn
Knoxville, Tennessee, United States, 37909
Sarah Cannon Cancer Center Centenniel Medical Center Recruiting
Nashville, Tennessee, United States, 37203-2173
Sarah Cannon Cancer Center Centenniel Medical Center Withdrawn
Nashville, Tennessee, United States, 37203-2173
OSU Martha Morehouse Medical Plaza Withdrawn
Nashville, Tennessee, United States, 37232-5536
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
Huntsman Cancer Institute Withdrawn
Salt Lake City, Utah, United States, 84112
United States, Washington
Medical Oncology Associates, PS Recruiting
Spokane, Washington, United States, 99208
France
Institut Bergonié Recruiting
Bordeaux, France, 33000
Hopital Ambroise Paré - APHP Hôpitaux Universitaires Paris I - Oncologie Thoracique Recruiting
Boulogne Billancourt, France, 92100
CHRU Côte de Nacre Recruiting
Caen Cedex, France, 14033
Centre Hospitalier Intercommunal de Créteil Recruiting
Creteil, France, 94010
CHI Creteil Withdrawn
Creteil, France, 94010
Centre Hospitalier Emile Muller Recruiting
Haut-Rhin, France, 68100
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Centre Leon Bérard Not yet recruiting
Lyon, France, 69373
CHU de Montpellier - Arnaud de Villeneuve Not yet recruiting
Montpellier, France, 34295
Polyclinique de Gentilly Recruiting
Nancy, France, 54000
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75908
Chu Rennes - Hopital Pontchaillou Recruiting
Rennes Cedex 9, France, 35033
CHU de Rouen Not yet recruiting
Rouen, France, 76031
Hopital Foch Not yet recruiting
Suresnes, France, 92151
CHU Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Gustave Roussy Withdrawn
Villejuif Cedex, France, 94805
Hungary
National Koranyi Institute of Pulmonology and TB Recruiting
Budapest, Hungary, 1121
SE Pulmonológiai Klinika Recruiting
Budapest, Hungary, 1125
Orszagos Koranyi Tbc es Pulmonologiai Intezet Recruiting
Budapest, Hungary, 1145
Orszagos Koranyi Tbc es Pulmonologiai Intezet Withdrawn
Budapest, Hungary, H-1529
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz Recruiting
Szekesfehervar, Hungary, 8000
Szent Borbala Hospital Tatabanya Recruiting
Tatabanya, Hungary, 2800
Poland
KO-MED Centra Kliniczne Sp. z o.o. Withdrawn
Biała Podlaska, Poland, 21-500
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Not yet recruiting
Lodz, Poland, 93-513
Mazowieckie Centrum Leczenia Chorob Pluc Not yet recruiting
Otwock, Poland, 05-400
Medical University Of Gdansk Not yet recruiting
Pomorskie, Poland, 80-952
Wojewodzki Szpital Specjalistyczny - Oddzial Pulmonologii Not yet recruiting
Radom, Poland, 26-617
Mazowiecki Szpital Onkologiczny - Oddzial Onkologiczny Not yet recruiting
Wieliszew, Poland, 05-135
Russian Federation
LLC VitaMed Withdrawn
Moscow, Russian Federation, 121309
BHI of Omsk Region Clinical Oncology Dispensary Withdrawn
Omsk, Russian Federation, 644013
Leningrad region clinical hospital Withdrawn
Saint Petersburg, Russian Federation, 194291
GBUZ Saint Petersburg clinical scientific and practical cent Withdrawn
Saint Petersburg, Russian Federation, 197758
N.N. Petrov Research Institute Of Oncology Withdrawn
Saint Petersburg, Russian Federation, 197758
First Pavlov State Medical University of Saint-Petersburg Withdrawn
Saint-Petersburg, Russian Federation, 197022
GBUZ Saint Petersburg clinical scientific and practical cent Withdrawn
Sankt-Peterburg, Russian Federation, 197758
GBUZ Oncology Centre #2 of Healthcare Department of Krasno Withdrawn
Sochi, Russian Federation, 354057
Spain
Hosp. Univ. Quiron Dexeus Recruiting
Barcelona, Spain, 08028
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hosp. Gral. Univ. de Elche Recruiting
Elche, Spain, 03203
Complejo Hospitalario de Jaen Recruiting
Jaén, Spain, 23007
Hosp. Univ. Severo Ochoa Recruiting
Leganés, Spain, 28911
Hosp. Univ. de La Princesa Withdrawn
Madrid, Spain, 28006
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Univ. Hm Sanchinarro Recruiting
Madrid, Spain, 28050
Hosp. Gral. Univ. J.M. Morales Meseguer Recruiting
Murcia, Spain, 30008
Hosp. Regional Univ. de Malaga Recruiting
Málaga, Spain, 29010
Hosp. Son Llatzer Recruiting
Palma De Mallorca, Spain, 07198
Hosp. Quiron Madrid Pozuelo Recruiting
Pozuelo De Alarcón, Spain, 28223
Hosp. Univ. Donostia Recruiting
San Sebastián, Spain, 20014
Hosp. Virgen Del Rocio Withdrawn
Seville, Spain, 41013
Hosp. Virgen Macarena Recruiting
Sótano, Spain, Sevilla
Hosp. Clinico Univ. de Valencia Recruiting
Valencia, Spain, 46010
Hosp. Arnau de Vilanova de Valencia Recruiting
Valencia, Spain, 46015
Hosp. Univ. I Politecni La Fe Withdrawn
Valencia, Spain, 46026
Hosp. Clinico Univ. Lozano Blesa Recruiting
Zaragoza, Spain, 50009
United Kingdom
North Middlesex University Hospital Withdrawn
London, United Kingdom, N18 1QX
Christie NHS Foundation Trust Withdrawn
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Janssen Research & Development, LLC
Genentech, Inc.
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03023423     History of Changes
Other Study ID Numbers: CR108256
2016-002579-83 ( EudraCT Number )
54767414LUC2001 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: December 9, 2016
First Posted: January 18, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atezolizumab
Daratumumab
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs