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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Atezolizumab; Drug: rHuPH20

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABD
    • Fundacion CENIT para la investigación en Neurociencias
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (Cori)
  • Salta, Argentina, 4400
    • Consultorio Dr. Miguel Ángel Escudero
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • INCA 1- Instituto Nacional de Câncer X
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Câncer do Estado de São Paulo - ICESP
• Chile
  • Recoleta, Chile, 8420383
    • Bradford Hill Centro de Investigaciones Clinicas
  • Temuco, Chile, 4800827
    • James Lind Centro de Investigacion del Cancer
  • Viña del Mar, Chile, 2520598
    • Oncocentro Apys
• China
  • Changchun, China, 132013
    • Jilin Cancer Hospital
  • Chengdu, China, 610047
    • West China Hospital - Sichuan University
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital Zhejiang University
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Costa Rica
  • San José, Costa Rica, 10103
    • Clinica CIMCA
  • San José, Costa Rica, 10108
    • ICIMED Instituto de Investigación en Ciencias Médicas
• France
  • Marseille, France, 13385
    • APHM
  • Saint-Herblain, France, 44805
    • Ico Rene Gauducheau
• Greece
  • Asvestochóri, Greece, 570 10
    • General Hospital "G.Papanikolaou"
  • Athens, Greece, 104 31
    • Sotiria Hospital
• Guatemala
  • Guatemala City, Guatemala, 01015
    • Grupo Angeles
  • Guatemala City, Guatemala, 01010
    • INTEGRA Cancer Institute
  • Guatemala City, Guatemala, 01010
    • Oncomedica
  • Guatemala City, Guatemala, 01015
    • Hospital El Pilar
• Hungary
  • Mátraháza, Hungary, 3233
    • Matrai Gyogyintezet
  • Törökbálint, Hungary, 2045
    • Reformatus Pulmonologiai Centrum
• Italy
  • Lombardy
    • Bergamo, Lombardy, Italy, 24128
      • ASST Papa Giovanni XXIII
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas
• Latvia
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
  • Querétaro
    • Querétaro City, Querétaro, Mexico, 76000
      • Cuidados Oncologicos
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital, Cancer and Blood Research
  • Christchurch, New Zealand
    • Christchurch Clinical Studies Trust Ltd
  • Hamilton, New Zealand, 3204
    • Waikato Hospital - Cancer and Blood Research Trials Unit
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital, Clinical Trials Unit
• Peru
  • Arequipa, Peru, 04001
    • Centro Medico Monte Carmelo
  • Lima, Peru, 41
    • Oncosalud Sac
  • Lima, Peru, Lima 41
    • Clinica Internacional, Sede San Borja
  • Lima, Peru, 15088
    • Clínica San Gabriel
• Poland
  • Grudzi?dz, Poland, 86-300
    • Regionalny Szpital Specjalistyczny im. W. Bieganskiego
  • Lodz, Poland, 93-319
    • Centrum Terapii Wspolczesnej
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
• Russia
  • Kaluga, Russia, 248007
    • SBIH Kaluga Region Clinical Oncology Dispensary
  • Murmansk, Russia, 183047
    • Murmansk Regional Clinical Hospital named after P.A. Bayandin
  • Samara, Russia, 443011
    • Multidisciplinary clinic Reaviz
  • Moscow Oblast
    • Chelyabinsk, Moscow Oblast, Russia, 454087
      • Chelyabinsk Regional Clinical Oncology Dispensary
    • Moscow, Moscow Oblast, Russia, 115478
      • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
    • Moscow, Moscow Oblast, Russia, 143422
      • MEDSI Clinical Hospital on Pyatnitsky Highway
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russia, 603081
      • Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
  • Respublika Mordoviya
    • Saransk, Respublika Mordoviya, Russia, 430032
      • Mordovia State University
• South Africa
  • Cape Town, South Africa, 7506
    • Groote Schuur Hospital ( Uni of Capetown )
  • Pretoria, South Africa, 0001
    • Wilgers Oncology Centre
  • Sandton, South Africa, 2196
    • Sandton Oncology Medical Group
• South Korea
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 135-170
    • Samsung Medical Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Bangkok, Thailand, 10300
    • Vajira Hospital
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.
  • Chanthaburi, Thailand, 22000
    • Prapokklao Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Hat Yai, Thailand, 90110
    • Prince of Songkla University
  • Muang,Udonthani, Thailand, 41330
    • Udonthani Cancer Hospital, Udonthani
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol University Medical Faculty
  • Izmir, Turkey (Türkiye), 35100
    • Ege Uni Medical Faculty Hospital
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Ivano-Frankivsk Regional Oncology Center
  • Sumy, Ukraine, 40005
    • RCI Sumy Regional Clinical Oncological Dispensary
  • Katerynoslav Governorate
    • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
      • Municipal Institution City Clinical Hospital #4 of Dnipro City Council
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61070
      • Communal Non profit Enterprise Regional Center of Oncology
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab (Part 2); Atezolizumab	Drug: Atezolizumab; Atezolizumab will be administered as per the schedule specified in arm or cohort.; Other Names: Tecentriq
Experimental: Cohort 2: Atezolizumab+rHuPH20 (Part 1); Atezolizumab+rHuPH20, followed by Atezolizumab	Drug: Atezolizumab; Atezolizumab will be administered as per the schedule specified in arm or cohort.; Other Names: Tecentriq; Drug: rHuPH20; rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.; Other Names: ENHANZE
Experimental: Cohort 3: Atezolizumab+rHuPH20(Part 1); Atezolizumab+rHuPH20, followed by Atezolizumab	Drug: Atezolizumab; Atezolizumab will be administered as per the schedule specified in arm or cohort.; Other Names: Tecentriq; Drug: rHuPH20; rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.; Other Names: ENHANZE
Experimental: Atezolizumab + rHuPH20 (Part 2); Atezolizumab + rHuPH20	Drug: Atezolizumab; Atezolizumab will be administered as per the schedule specified in arm or cohort.; Other Names: Tecentriq; Drug: rHuPH20; rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.; Other Names: ENHANZE
Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1); Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab	Drug: Atezolizumab; Atezolizumab will be administered as per the schedule specified in arm or cohort.; Other Names: Tecentriq; Drug: rHuPH20; rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.; Other Names: ENHANZE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1	Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)
Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1	Predose on Day 1 of Cycle 2 (Cycle length =21 days)
Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1	From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab		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)
Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab		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)
Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab		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)
Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1		Cycle 1 (Cycle length=21 days)
Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab	1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo	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)
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.	Cohort 1: Predose: D1 & postdose: D1, 3, 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
Part 1: Percentage of Participants With Adverse Events (AEs)	An AE was 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 AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place.	From initiation of study treatment up to approximately 69 months
Part 2: Percentage of Participants With AEs	An AE was 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 AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place.	From initiation of study treatment up to approximately 44.7 months
Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab	1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.	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)
Part 2: Objective Response Rate (ORR)	ORR was 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 Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place.	Up to approximately 25 months
Part 2: Progression-free Survival (PFS)	PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method.	Up to approximately 25 months
Part 2: Overall Survival (OS)	OS was defined as the time from the date of study randomization to the date of death from any cause.	Up to approximately 44.7 months
Part 2: Duration of Response (DOR)	DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm.	Up to approximately 25 months
Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score	EORTC IL57 questionnaire has 10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC IL. 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 indicates better outcome.	Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
Part 2: Change From Baseline in EORTC IL57 Role Functioning Score	EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. 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 indicates better outcome.	Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
Part 2: Change From Baseline in EORTC IL57 Global Health Status Score	EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. 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 indicates better outcome.	Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
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 consisted of seven items that measured 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 were linearly transformed to obtain scores from 0-100, where 100 was the best possible score. Higher scores indicate higher satisfaction. Here, data for 'overall satisfaction' domain has been presented.	Day 1 Cycle 3 or Treatment Discontinuation Visit (if treatment discontinued at any visit before Cycle 3) (Cycle length = 21 days)
Part 2: Percentage of Participants by Their Responses to 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 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 were answered on a 4-point Likert scale, where 1="Not at all" to 4="Very much". Higher scores indicated greater AE burden. Percentages have been rounded to one decimal place.	Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, and 64 (Cycle length = 21 days)
Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration	The percentage of ADA-positive participants after atezolizumab administration was reported. Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.	From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration	The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.	From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire	The HCP SC versus IV Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Which formulation of atezolizumab (SC or IV) do you think is more convenient for you? Responses to this question are reported in the data table. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'first participant in [FPI]' date to 'last participant last visit [LPLV]' for Part 2).	After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire	The HCP SC versus IV Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: If used in routine practice, do you think administering atezolizumab SC could save staff time compared to atezolizumab IV? The responses to this question could be Yes; No; Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2).	After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire	The HCP SC versus IV Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, were you more satisfied with atezolizumab SC or atezolizumab IV? The responses included: More satisfied with atezolizumab SC; Equally satisfied with both formulations; More satisfied with atezolizumab IV. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2).	After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire	The HCP SC Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Do you think atezolizumab SC is convenient? The responses to this question could be: Yes; No; and Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.	After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire	The HCP SC Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: Overall, how easy did you find atezolizumab SC administration? The responses to this question could be: Very easy; Fairly easy; Not at all easy. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.	After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire	The HCP SC Perspective Questionnaire consisted 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. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, how satisfied were you with atezolizumab SC? The responses to this question could be: Very satisfied; Satisfied; Dissatisfied; Very dissatisfied. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.	After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• Burotto M, Zvirbule Z, Mochalova A, Runglodvatana Y, Herraez-Baranda L, Liu SN, Chan P, Shearer-Kang E, Liu X, Tosti N, Zanghi JA, Leutgeb B, Felip E. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023 Aug;34(8):693-702. doi: 10.1016/j.annonc.2023.05.009. Epub 2023 Jun 1.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; atezolizumab
• Other Study ID Numbers: BP40657; 2018-002328-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No