A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Part of paid clinical trials in Brick, New Jersey.

Sponsor
Hoffmann-La Roche
Study ID
NCT05171777
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC.

Study Details

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

Key Dates

Start date
Apr 4, 2022
Status verified
Nov 2025
Primary completion
Nov 9, 2023
Completion
Oct 25, 2024

Study Design

Enrollment
179 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Participants will receive atezolizumab SC followed by atezolizumab IV.
  • Experimental: Treatment B
    Participants will receive atezolizumab IV followed by atezolizumab SC.

Primary Outcome Measure

Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) [ Time Frame: Cycle 6 Day 1 (cycle length=21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
New Jersey Hematology Oncology Associates LLCBrickNew Jersey08724-3009-
Tri County HematologyoncologyMassillonOhio44646-9128-
Asante Rogue Regional Medical CenterMedfordOregon97504-8332-
UPMC - Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Brick, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
New Jersey Hematology Oncology Associates LLC· Brick, NJTri County Hematologyoncology· Massillon, OHAsante Rogue Regional Medical Center· Medford, ORUPMC - Hillman Cancer Center· Pittsburgh, PA

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