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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Atezolizumab

rHuPH20

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known EGFR status

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)

• Tested tumor PD-L1 expression status with an intention to treat the patient if positive

Sites / Locations

Fundación CENIT para la Investigación en Neurociencias
Centro Oncologico Riojano Integral (CORI)
Consultorio Dr. Miguel Angel Escudero
INCA 1- Instituto Nacional de Câncer X
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Hospital das Clinicas - UFRGS
Hospital Nossa Senhora da Conceicao
Instituto do Cancer do Estado de Sao Paulo - ICESP
Bradford Hill Centro de Investigaciones Clinicas
James Lind Centro de Investigación Del Cáncer
ONCOCENTRO APYS; Oncología
Beijing Cancer Hospital
Jilin Cancer Hospital
West China Hospital - Sichuan University
Cancer Center of Guangzhou Medical University
Sir Run Run Shaw Hospital Zhejiang University
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Harbin Medical University Cancer Hospital
Jinan Central Hospital
Tianjin Cancer Hospital
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Henan Cancer Hospital
Clinica CIMCA
ICIMED Instituto de Investigación en Ciencias Médicas
Aphm; Cpcet
Ico Rene Gauducheau; Oncologie
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
Sotiria Hospital
INTEGRA Cancer Institute
Hospital El Pilar
Grupo Angeles
Oncomedica
Matrai Gyogyintezet
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Tudogyogyintezet Torokbalint
Asst Papa Giovanni XXIII; Oncologia Medica
IRCCS Istituto Clinico Humanitas; Oncologia
Asan Medical Center
Samsung Medical Centre; Medical Oncology
Riga East Clinical University Hospital Latvian Oncology Centre
Health Pharma Professional Research
Cuidados oncologicos
Auckland City Hospital, Cancer and Blood Research
Christchurch Clinical Studies Trust Ltd
Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Centro Medico Monte Carmelo
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
Oncosalud Sac; Oncología
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Szpital Morski Im. Pck; Oncology & Radiotherapy Dept
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej
Centrum Terapii Wspolczesnej
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz
Mordovia State University
Chelyabinsk Regional Clinical Oncology Dispensary
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
SBIH Kaluga Region Clinical Oncology Dispensary
Murmansk Regional Clinical Hospital named after P.A. Bayandin
Multidisciplinary clinic Reaviz
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
Richards Bay Oncology Centre
Wilgers Oncology Centre
Sandton Oncology Medical Group
Hospital Universitari Vall d'Hebron
Hospital Universitario La Paz; Servicio de Oncologia
Vajira Hospital
Chulalongkorn Hospital; Medical Oncology
Rajavithi Hospital; Division of Medical Oncology
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Prapokklao Hospital
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine
Khonkaen Hospital
Udonthani Cancer Hospital, Udonthani
Ankara Bilkent City Hospital
Medipol University Medical Faculty; Oncology Department
Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
Ege Uni Medical Faculty Hospital; Oncology Dept
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Municipal Institution City Clinical Hospital #4 of Dnipro City Council
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
Ivano-Frankivsk Regional Oncology Center
RCI Sumy Regional Clinical Oncological Dispensary
Birmingham Heartlands Hospital
St James Hospital; Dept of Oncology/Hematology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Atezolizumab (Part 2)

Cohort 1: Atezolizumab+rHuPH20 (Part 1)

Cohort 2: Atezolizumab+rHuPH20 (Part 1)

Cohort 3: Atezolizumab+rHuPH20(Part 1)

Atezolizumab + rHuPH20 (Part 2)

Arm Description

Atezolizumab

Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab

Atezolizumab+rHuPH20, followed by Atezolizumab

Atezolizumab + rHuPH20

Outcomes

Primary Outcome Measures

Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1

Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1

Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1

Secondary Outcome Measures

Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab

Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab

Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration

Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.

Part 1: Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0).

Part 2: Percentage of Participants With AEs

Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1

Part 2: Model Predicted Ctrough at Steady State (Cthrough,ss) of Atezolizumab

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.

Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo

Part 2: Objective Response Rate (ORR)

ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

Part 2: Progression-Free Survival (PFS)

PFS is defined as the time from study start to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or or death from any cause (whichever occurs first).

Part 2: Overall Survival (OS)

OS defined as the time from study entry to death from any cause.

Part 2: Duration of Response (DOR)

DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

Part 2: Functioning and Global Health Status Over Time, as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)57

EORTC IL57 questionnaire has10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC Item Library. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score. Higher score = better outcome.

Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)

Modified SWT scale of the CTSQ consist of seven items that measures seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score Higher scores are associated with higher satisfaction.

Part 2: Overall Patient-reported AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57

The overall patient-reported AE burden was assessed using the a single item from the EORTC IL57 questionnaire i.e To what extent have you been troubled with side-effects from your treatment?. The questions is answered on a 4-point Likert scale where 1="Not at all" to 4="Very much". Higher scores indicates greater AE burden.

Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration

Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration Relative to the Prevalence of ADAs at Baseline

Part 2: Convenience, Potential Time Savings, and Overall Satisfaction With Atezolizumab SC Compared With Atezolizumab IV as Assessed by the Health Care Professional (HCP) SC Versus IV Perspective Questionnaire

The HCP Subcutaneous Versus IV Perspective Questionnaire consists of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction.

Part 2: Convenience, Ease of Administration, and Overall Satisfaction With Atezolizumab SC Assessed Using HCP Subcutaneous Perspective Questionnaire

The HCP Subcutaneous Perspective Questionnaire consists of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction.

Full Information

NCT ID

NCT03735121

First Posted

November 7, 2018

Last Updated

October 3, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03735121

Brief Title

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

Official Title

A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 14, 2018 (Actual)

Primary Completion Date

April 26, 2022 (Actual)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Model Description

Intervention study model can be sequential or in parallel.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

438 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atezolizumab (Part 2)

Arm Type

Experimental

Arm Description

Atezolizumab

Arm Title

Cohort 1: Atezolizumab+rHuPH20 (Part 1)

Arm Type

Experimental

Arm Description

Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab

Arm Title

Cohort 2: Atezolizumab+rHuPH20 (Part 1)

Arm Type

Experimental

Arm Description

Atezolizumab+rHuPH20, followed by Atezolizumab

Arm Title

Cohort 3: Atezolizumab+rHuPH20(Part 1)

Arm Type

Experimental

Arm Description

Atezolizumab+rHuPH20, followed by Atezolizumab

Arm Title

Atezolizumab + rHuPH20 (Part 2)

Arm Type

Experimental

Arm Description

Atezolizumab + rHuPH20

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Other Intervention Name(s)

Tecentriq

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rHuPH20

Other Intervention Name(s)

ENHANZE

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Title

Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1

Time Frame

Predose on Day 1 of Cycle 2 (Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2)

Title

Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1

Time Frame

From start of dosing up to Day 21 in Cycle 1 (Cycle length= 21 days)

Secondary Outcome Measure Information:

Title

Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Time Frame

Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)

Title

Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab

Time Frame

Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)

Title

Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab

Time Frame

Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2)

Title

Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration

Description

Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.

Time Frame

Cohort 1: Pre&postdose:D1 &postdose: D3,8 of C1; Cohort 2: Pre&postdose: D1 of C1,3 & postdose: D3,8 of C1, Predose: D1 of C2; Cohort 3: Pre& postdose: D1 of C1,2 & postdose: D3,8 of C1, D2,4& 9 of C2& pre dose:D1 of C3

Title

Part 1: Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to data cutoff date for primary analysis, April 26, 2022 (up to approximately 17 months)

Title

Part 2: Percentage of Participants With AEs

Description

Time Frame

From signing of informed consent form (ICF) until 30 days after last dose of study drug administration in Part 2 (Up to approximately 72 months)

Title

Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1

Time Frame

Cycle 1 (Cycle length=21 days)

Title

Part 2: Model Predicted Ctrough at Steady State (Cthrough,ss) of Atezolizumab

Description

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.

Time Frame

Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)

Title

Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab

Description

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo

Time Frame

Title

Part 2: Objective Response Rate (ORR)

Description

Time Frame

From treatment initiation until disease progression or loss of clinical benefit (Up to approximately 72 months).

Title

Part 2: Progression-Free Survival (PFS)

Description

Time Frame

From study start to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 72 months).

Title

Part 2: Overall Survival (OS)

Description

OS defined as the time from study entry to death from any cause.

Time Frame

From study start to death from any cause (Up to approximately 72 months)

Title

Part 2: Duration of Response (DOR)

Description

Time Frame

From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 72 months)

Title

Part 2: Functioning and Global Health Status Over Time, as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)57

Description

Time Frame

From Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)

Title

Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)

Description

Time Frame

Day 1 Cycle 3 or at treatment discontinuation visit (Up to approximately 72 months)

Title

Part 2: Overall Patient-reported AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57

Description

Time Frame

Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)

Title

Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration

Time Frame

From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months).

Title

Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration Relative to the Prevalence of ADAs at Baseline

Time Frame

From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months)

Title

Description

Time Frame

After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 72 months)

Title

Part 2: Convenience, Ease of Administration, and Overall Satisfaction With Atezolizumab SC Assessed Using HCP Subcutaneous Perspective Questionnaire

Description

Time Frame

After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 72 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy ≥12 weeks Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status Exclusion Criteria: Symptomatic, untreated, or actively progressing central nervous system (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) • Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Fundación CENIT para la Investigación en Neurociencias

City

Buenos Aires

ZIP/Postal Code

C1125ABD

Country

Argentina

Facility Name

Centro Oncologico Riojano Integral (CORI)

City

La Rioja

ZIP/Postal Code

F5300COE

Country

Argentina

Facility Name

Consultorio Dr. Miguel Angel Escudero

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

INCA 1- Instituto Nacional de Câncer X

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

City

Ijui

State/Province

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Hospital das Clinicas - UFRGS

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital Nossa Senhora da Conceicao

City

Porto Alegre

State/Province

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Instituto do Cancer do Estado de Sao Paulo - ICESP

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Bradford Hill Centro de Investigaciones Clinicas

City

Recoleta

ZIP/Postal Code

8420383

Country

Chile

Facility Name

James Lind Centro de Investigación Del Cáncer

City

Temuco

ZIP/Postal Code

4800827

Country

Chile

Facility Name

ONCOCENTRO APYS; Oncología

City

Vina Del Mar

ZIP/Postal Code

2520598

Country

Chile

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Jilin Cancer Hospital

City

Changchun

ZIP/Postal Code

132013

Country

China

Facility Name

West China Hospital - Sichuan University

City

Chengdu City

ZIP/Postal Code

610047

Country

China

Facility Name

Cancer Center of Guangzhou Medical University

City

Guangzhou

ZIP/Postal Code

510000

Country

China

Facility Name

Sir Run Run Shaw Hospital Zhejiang University

City

Hangzhou City

ZIP/Postal Code

310016

Country

China

Facility Name

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

City

Hangzhou City

ZIP/Postal Code

310022

Country

China

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Jinan Central Hospital

City

Jinan City

ZIP/Postal Code

250013

Country

China

Facility Name

Tianjin Cancer Hospital

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

City

Wuhan

ZIP/Postal Code

430023

Country

China

Facility Name

Henan Cancer Hospital

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Clinica CIMCA

City

San José

ZIP/Postal Code

10103

Country

Costa Rica

Facility Name

ICIMED Instituto de Investigación en Ciencias Médicas

City

San José

ZIP/Postal Code

10108

Country

Costa Rica

Facility Name

Aphm; Cpcet

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Ico Rene Gauducheau; Oncologie

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

General Hospital "G.Papanikolaou"; Pulmonogy Clinic

City

Asvestochori

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Sotiria Hospital

City

Athens

ZIP/Postal Code

104 31

Country

Greece

Facility Name

INTEGRA Cancer Institute

City

Ciudad de Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Hospital El Pilar

City

Ciudad de Guatemala

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Grupo Angeles

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Oncomedica

City

Guatemala

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Matrai Gyogyintezet

City

Matrahaza

ZIP/Postal Code

3233

Country

Hungary

Facility Name

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Tudogyogyintezet Torokbalint

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Asst Papa Giovanni XXIII; Oncologia Medica

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

Country

Italy

Facility Name

IRCCS Istituto Clinico Humanitas; Oncologia

City

Rozzano

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Centre; Medical Oncology

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Riga East Clinical University Hospital Latvian Oncology Centre

City

Riga

ZIP/Postal Code

LV-1079

Country

Latvia

Facility Name

Health Pharma Professional Research

City

Cdmx

State/Province

Mexico CITY (federal District)

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Cuidados oncologicos

City

Querétaro

State/Province

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Auckland City Hospital, Cancer and Blood Research

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Christchurch Clinical Studies Trust Ltd

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

City

Tauranga

ZIP/Postal Code

3112

Country

New Zealand

Facility Name

Centro Medico Monte Carmelo

City

Arequipa

ZIP/Postal Code

04001

Country

Peru

Facility Name

Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

City

Lima

ZIP/Postal Code

15088

Country

Peru

Facility Name

Oncosalud Sac; Oncología

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

City

Lima

ZIP/Postal Code

Lima 41

Country

Peru

Facility Name

Szpital Morski Im. Pck; Oncology & Radiotherapy Dept

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Facility Name

Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

City

Grudzi?dz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Centrum Terapii Wspolczesnej

City

Lodz

ZIP/Postal Code

90-338

Country

Poland

Facility Name

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology

City

Otwock

ZIP/Postal Code

05-400

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Mordovia State University

City

Saransk

State/Province

Mordovija

ZIP/Postal Code

430032

Country

Russian Federation

Facility Name

Chelyabinsk Regional Clinical Oncology Dispensary

City

Chelyabinsk

State/Province

Moskovskaja Oblast

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

143422

Country

Russian Federation

Facility Name

Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

City

Nizhny Novgorod

State/Province

Niznij Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

SBIH Kaluga Region Clinical Oncology Dispensary

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Facility Name

Murmansk Regional Clinical Hospital named after P.A. Bayandin

City

Murmansk

ZIP/Postal Code

183047

Country

Russian Federation

Facility Name

Multidisciplinary clinic Reaviz

City

Samara

ZIP/Postal Code

443011

Country

Russian Federation

Facility Name

Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

City

Cape Town

ZIP/Postal Code

7506

Country

South Africa

Facility Name

Richards Bay Oncology Centre

City

KwaZulu Natal

ZIP/Postal Code

3900

Country

South Africa

Facility Name

Wilgers Oncology Centre

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Sandton Oncology Medical Group

City

Sandton

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Universitario La Paz; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Vajira Hospital

City

Bangkok

ZIP/Postal Code

10300

Country

Thailand

Facility Name

Chulalongkorn Hospital; Medical Oncology

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Rajavithi Hospital; Division of Medical Oncology

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Prapokklao Hospital

City

Chanthaburi

ZIP/Postal Code

22000

Country

Thailand

Facility Name

Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

City

ChiangMai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

City

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Khonkaen Hospital

City

Khonkaen

ZIP/Postal Code

40000

Country

Thailand

Facility Name

Udonthani Cancer Hospital, Udonthani

City

Muang,Udonthani

ZIP/Postal Code

41330

Country

Thailand

Facility Name

Ankara Bilkent City Hospital

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Medipol University Medical Faculty; Oncology Department

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Facility Name

Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

City

Istanbul

ZIP/Postal Code

34865

Country

Turkey

Facility Name

Ege Uni Medical Faculty Hospital; Oncology Dept

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

City

Sihhiye/Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Municipal Institution City Clinical Hospital #4 of Dnipro City Council

City

Dnipropetrovsk

State/Province

Katerynoslav Governorate

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

City

Kharkiv

State/Province

Kharkiv Governorate

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Ivano-Frankivsk Regional Oncology Center

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

RCI Sumy Regional Clinical Oncological Dispensary

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

Birmingham Heartlands Hospital

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

St James Hospital; Dept of Oncology/Hematology

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33788415

Citation

Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31.

Results Reference

derived

Learn more about this trial

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

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