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Atezolizumab subcutaneous vs intravenous in NSCLC
NCT03735121Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2018
- Primary completion
- Apr 2022
- Countries
- 23
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies
- Drugs
- atezolizumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised trial of atezolizumab in non-small cell lung cancer (NSCLC) (5 arms), sponsored by Roche. Primary endpoints: Serum Trough Concentration of Atezolizumab at Cycle 1 at 3 weeks, Observed Serum Trough Concentration of Atezolizumab at Cycle 1 at 3 weeks and 1 more. Started Dec 2018; status: completed.
02
Design
5 arms- Study design
- Randomized
Atezolizumab IV (Part 2)
Intravenous atezolizumab 1200 mg Q3W
Cohort 1: Atezolizumab SC + rHuPH20 (Part 1)
Subcutaneous atezolizumab with rHuPH20, dose finding cohort 1
Cohort 2: Atezolizumab SC + rHuPH20 (Part 1)
Subcutaneous atezolizumab with rHuPH20, dose finding cohort 2
Cohort 3: Atezolizumab SC + rHuPH20 (Part 1)
Subcutaneous atezolizumab with rHuPH20, dose finding cohort 3
Atezolizumab SC + rHuPH20 (Part 2)
Subcutaneous atezolizumab with rHuPH20 at selected dose from Part 1
03
Who it enrols
Patients with histologically or cytologically documented locally advanced or metastatic NSCLC who have failed prior platinum-based therapy or recurred within 6 months of adjuvant/neoadjuvant platinum therapy, with ECOG 0-1, no prior cancer immunotherapy, and adequate organ function. Part 2 requires known EGFR status and available tissue.
04
Endpoints
Primary
Serum Trough Concentration of Atezolizumab at Cycle 1
Observed Serum Trough Concentration of Atezolizumab at Cycle 1
Area Under the Concentration-Time Curve From Time Zero to 21 Days at Cycle 1
Secondary
Maximum Observed Serum Concentration of Atezolizumab
Time to Maximum Serum Concentration of Atezolizumab
Area Under the Concentration-time Curve of Atezolizumab
Serum Atezolizumab Concentration at Specified Timepoints During SC Administration
Percentage of Participants With Adverse Events
Model Predicted Trough Concentration of Atezolizumab at Cycle 1
Model Predicted Trough Concentration at Steady State of Atezolizumab
Model Predicted Area Under the Curve at Steady State of Atezolizumab
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