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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03735121




Registration number
NCT03735121
Ethics application status
Date submitted
7/11/2018
Date registered
8/11/2018
Date last updated
26/02/2020

Titles & IDs
Public title
A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer (IMscin001)
Scientific title
A Two-Part Phase Ib/II Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous in Patients With Stage IV Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
BP40657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - rHuPH20

Experimental: Atezolizumab+Bevacizumab+Chemotherapy (Part 2) -

Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1) - Atezolizumab+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


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered as per the schedule specified in the arm.

Treatment: Drugs: Carboplatin
Carboplatin will be administered as per the schedule specified in the arm.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as per the schedule specified in the arm.

Treatment: Drugs: rHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 1
Timepoint [1] 0 0
Predose of Cycle 2. Cycle length is 21 days.
Primary outcome [2] 0 0
Observed Concentration of Atezolizumab in Serum at Cycle 1 in Part 2
Timepoint [2] 0 0
Predose of Cycle 2. Cycle length is 21 days.
Secondary outcome [1] 0 0
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Atezolizumab in Part 1
Timepoint [1] 0 0
At Cycle 1. Cycle length is 21 days.
Secondary outcome [2] 0 0
Concentration at the End of a Dosing Interval (Ctrough) of Atezolizumab in Part 1
Timepoint [2] 0 0
At Cycles 1-4, 7, 11 and 15 and at treatment discontinuation visit. Each cycle is 21 days.
Secondary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Part 1
Timepoint [3] 0 0
At Cycles 1-5, 8, 12 and 16. Each cycle is 21 days.
Secondary outcome [4] 0 0
Time to Maximum Plasma Concentration (Tmax) of Atezolizumab in Part 1
Timepoint [4] 0 0
At Cycles 1-5, 8, 12 and 16. Each cycle is 21 days.
Secondary outcome [5] 0 0
Percentage of Participants with Adverse Events in Part 1 and Part 2
Timepoint [5] 0 0
Up to 4.6 years
Secondary outcome [6] 0 0
Objective Response Rate (ORR) in Part 2 - ORR is defined as the proportion of patients with a partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1.
Timepoint [6] 0 0
Up to 4.6 years
Secondary outcome [7] 0 0
Progression-Free Survival (PFS) in Part 2 - PFS is defined as the time from the date of study entry to the date of documented disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever is earlier.
Timepoint [7] 0 0
Up to 4.6 years
Secondary outcome [8] 0 0
Overall Survival (OS) in Part 2
Timepoint [8] 0 0
Up to 4.6 years

Eligibility
Key inclusion criteria
- Histologically or cytologically documented locally advanced or metastatic NSCLC

- Prior platinum-containing regimen or disease recurrence = 6 months since prior
platinum-based adjuvant/neoadjuvant regimen.

- Measurable disease as defined by RECIST v1.1

- ECOG Performance Status of 0 or 1

- Life expectancy =12 weeks

- Adequate hematologic and end-organ function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Symptomatic, untreated, or actively progressing CNS metastases

- Uncontrolled or symptomatic hypercalcemia

- Pregnancy or breastfeeding

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

- Severe infection = 4 weeks

- Treatment with therapeutic oral or IV antibiotics = 2 weeks prior to study treatment

- Significant cardiovascular disease

- Prior allogeneic stem cell or solid organ transplantation

- Treatment with a live, attenuated vaccine = 4 weeks

- Treatment with systemic immunostimulatory agents = 4 weeks or 5 half-lives of the drug

- Treatment with systemic immunosuppressive medication = 2 weeks

Additional Exclusion Criteria (Part 2 Only)

- No prior anticancer treatment for NSCLC, CD137 agonists or immune checkpoint
inhibitors

- Uncontrolled hypertension, history of hypertensive crisis or hypertensive
encephalopathy

- Significant vascular disease = 6 months

- History of hemoptysis = 1 month

- Evidence of active bleeding, bleeding diathesis or coagulopathy

- Current or recent use of aspirin or with dipyramidole, ticlopidine, clopidogrel, and
cilostazol

- Current use of anticoagulants or thrombolytic agents for therapeutic purposes unstable
for > 2 weeks prior to enrollment

- History of abdominal or tracheosphageal fistula or gastrointestinal perforation = 6
months

- Clinical signs of gastrointestinal obstruction or requirement for routine treatment

- Evidence of abdominal free air not explained by paracentesis or recent surgical
procedure

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Proteinuria

- Clear tumor infiltration into the thoracic great vessels or cavitation of pulmonary
lesions

- Grade = 2 peripheral neuropathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Recoleta
Country [2] 0 0
France
State/province [2] 0 0
Marseille
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
France
State/province [4] 0 0
Saint Herblain
Country [5] 0 0
Italy
State/province [5] 0 0
Lombardia
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Latvia
State/province [7] 0 0
Riga
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
Poland
State/province [9] 0 0
Grudziadz
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
Spain
State/province [11] 0 0
Navarra
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Birmingham
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab
subcutaneous (SC) in patients with Non-Small Cell Lung Cancer (NSCLC). A dose-finding part
(Part 1) will aim to identify the dose of atezolizumab SC that yields drug exposure that is
comparable to that of atezolizumab IV. A dose-confirmation part (Part 2) will aim to
demonstrate the non inferiority of observed drug exposure following treatment with
atezolizumab SC at the identified dose compared with historical drug exposure following
treatment with atezolizumab IV.
Trial website
https://clinicaltrials.gov/show/NCT03735121
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP40657 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03735121