A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT03735121
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered as per the schedule specified in arm or cohort.
  • rHuPH20 — DRUG
    rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Study Details

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

Key Dates

Start date
Dec 27, 2018
Status verified
Nov 2025
Primary completion
Apr 26, 2022
Completion
Nov 11, 2024

Study Design

Enrollment
438 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab (Part 2)
    Atezolizumab
  • Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1)
    Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab
  • Experimental: Cohort 2: Atezolizumab+rHuPH20 (Part 1)
    Atezolizumab+rHuPH20, followed by Atezolizumab
  • Experimental: Cohort 3: Atezolizumab+rHuPH20(Part 1)
    Atezolizumab+rHuPH20, followed by Atezolizumab
  • Experimental: Atezolizumab + rHuPH20 (Part 2)
    Atezolizumab + rHuPH20

Primary Outcome Measure

Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 [ Time Frame: Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2) ]

Related Studies