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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03023423
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab 1200 mg intravenously.
  • Daratumumab — DRUG
    Participants will receive daratumumab 16 mg/kg intravenously.

Study Details

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.

Key Dates

Start date
Dec 23, 2016
Status verified
Nov 2019
Primary completion
May 17, 2018
Completion
Sep 26, 2019

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: Up to 1.5 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
-Loma LindaCalifornia--
-WhittierCalifornia--
-NewarkDelaware--
-Deerfield BeachFlorida--
-Fort LauderdaleFlorida--
-OrlandoFlorida--
-TampaFlorida--
-AthensGeorgia--
-AtlantaGeorgia--
-New OrleansLouisiana--
-BethesdaMaryland--
-Oklahoma CityOklahoma--
-ChattanoogaTennessee--
-KnoxvilleTennessee--
-NashvilleTennessee--
-SpokaneWashington--

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