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

NCT03023423 | Completed Phase 1 Results DMC

• 3 other identifiers: CR1082562016-002579-8354767414LUC2001
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 47

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Response Rate (ORR)

  ORR was 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. Criteria for CR: Disappearance of all target lesions; all lymph nodes must be of non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis; normalization of tumor marker level. Criteria for PR: greater than or equal to (\>=)30 percent (%) decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Overall Response (OR) = CR + PR. The outcome measure (OM) was planned to be reported for participants based on their initial assignment to Randomized Phase: Atezolizumab'.

  Up to 1.5 years

Secondary Outcomes (9)

• Number of Participants With Adverse Events

  Up to 1.5 years

• Duration of Response (DoR)

  Up to 1.5 years

• Clinical Benefit Rate

  Up to 1.5 years

• Progression-Free Survival (PFS)

  Up to 1.5 years

• Overall Survival (OS)

  Up to 1.5 years

Study Arms (2)

Treatment Arm A: Atezolizumab

EXPERIMENTAL

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

Treatment Arm B: Atezolizumab and Daratumumab

EXPERIMENTAL

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; Drug: Daratumumab

Interventions

Atezolizumab DRUG

Participants will receive atezolizumab 1200 mg intravenously.

Treatment Arm A: Atezolizumab; Treatment Arm B: Atezolizumab and Daratumumab

Daratumumab DRUG

Participants will receive daratumumab 16 mg/kg intravenously.

Also known as: JNJ-54767414

Treatment Arm B: Atezolizumab and Daratumumab

Eligibility Criteria

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

You may qualify if:

• 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
• Tumor cell programmed death-ligand 1 (PD-L1) score of tumor cells (TC)1-3 and immune cell PD-L1 score of tumor-infiltrating immune cells (IC)0-3 as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained after the last line of therapy
• 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
• 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

You may not qualify if:

• Received any of the following prescribed medications or therapies in the past:
• Anti-cluster of differentiation(CD)38 therapy, including daratumumab
• 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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (47)

Unknown Facility

Loma Linda, California, United States

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Whittier, California, United States

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Newark, Delaware, United States

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Deerfield Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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New Orleans, Louisiana, United States

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Bethesda, Maryland, United States

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Oklahoma City, Oklahoma, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Spokane, Washington, United States

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Bordeaux, France

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Boulogne-Billancourt, France

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Caen, France

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Créteil, France

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Haut-Rhin, France

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Montpellier, France

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Nancy, France

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Paris, France

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Rennes, France

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Rouen, France

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Suresnes, France

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Vandœuvre-lès-Nancy, France

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Budapest, Hungary

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Székesfehérvár, Hungary

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Tatabánya, Hungary

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Lodz, Poland

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Otwock, Poland

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Wieliszew, Poland

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Barcelona, Spain

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Elche, Spain

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Jaén, Spain

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Leganés, Spain

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Madrid, Spain

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Málaga, Spain

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Murcia, Spain

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Palma de Mallorca, Spain

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Pozuelo de Alarcón, Spain

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San Sebastián, Spain

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Sótano, Spain

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Valencia, Spain

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Zaragoza, Spain

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; daratumumab

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: Executive Medical Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: January 18, 2017
• Study Start: December 23, 2016
• Primary Completion: May 17, 2018
• Study Completion: September 26, 2019
• Last Updated: November 20, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-11

Locations

ES (13); FR (12); US (16); PL (3); HU (3)