AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2NCT05171777

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

A Phase 2 study testing Atezolizumab in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 36 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
36 sitesin 12 countries
Study dates
4 Apr 2022to 25 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance status of 0 or 1
  • Participants must have a complete resection of a histologically or cytologically confirmed Stage II, IIIA, and selected IIIB (T3-N2) NSCLC
  • PD-L1 expression TC ≥ 1% or TPS ≥ 1%
  • Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy. For participants in the adjuvant setting, neoadjuvant chemotherapy or chemoradiotherapy is acceptable provided that participants also received adjuvant chemotherapy as per protocol's requirement.
  • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  • Life expectancy ≥ 18 weeks in the opinion of the investigator
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  • PD-L1 expression TC ≥ 50% or TPS ≥ 50% or TC3 or IC3
  • No prior systemic treatment for Stage IV non-squamous or squamous NSCLC
  • Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle.

Who cannot join

  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
  • History of leptomeningeal disease
  • Uncontrolled or symptomatic hypercalcemia
Show all 10Show fewer
  • 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 on screening chest computed tomography (CT) scan
  • Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Trial locations and contacts

36 sites in 12 countries.

36 sites in 12 countries

Spain6 sites
  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

United States4 sites
  • New Jersey Hematology Oncology Associates LLC

    Brick, New Jersey, 08724-3009

  • Tri County Hematologyoncology

    Massillon, Ohio, 44646-9128

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504-8332

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

Brazil4 sites
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Finland4 sites
  • Oulun yliopistollinen sairaala (OYS)

    Oulu, 90220

  • Tampereen yliopistollinen sairaala (TAYS)

    Tampere, 33521

  • Turun yliopistollinen keskussairaala (TYKS)

    Turku, 20521

  • Vaasan Keskussairaala

    Vaasa, 65130

Other trials in Finland

Italy4 sites
  • Instituto Europeo di Oncologia

    Milan, Lombardy, 20141

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • IRCCS Istituto Regina Elena (IFO)

    Rome, Lazio, 00144

  • Azienda Ospedaliera Universitaria Senese

    Siena, Abruzzo, 53100

Other trials in Italy

Argentina3 sites
  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • CEMIC

    Buenos Aires, C1431FWN

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE

Other trials in Argentina

Canada2 sites
  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

Other trials in Canada

Costa Rica2 sites
  • Clinica CIMCA

    San José, 10103

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108

Other trials in Costa Rica

Latvia2 sites
  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Poland2 sites
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

Other trials in Poland

South Korea2 sites
  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Chile1 site
  • OrlandiOncología

    Santiago, 7500713

Other trials in Chile

About this study

Official title: A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC.

Study groups in NCT05171777
Study groupRoleWhat they receive
Treatment AExperimentalParticipants will receive atezolizumab SC followed by atezolizumab IV.
Receives: Drug: Atezolizumab
Treatment BExperimentalParticipants will receive atezolizumab IV followed by atezolizumab SC.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)

    Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS.

    Measured: Cycle 6 Day 1 (cycle length=21 days)

Secondary outcomes (27)
  1. Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV)

    TASQ is a 12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Crossover Period. Participants satisfaction was assessed based on the Question 1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant did not answer the question). Question 1 - TASQ- IV (How satisfied or dissatisfied were you with the IV infusion?) and TASQ- SC (How satisfied or dissatisfied were you with the SC injection?)

    Measured: Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days)

  2. Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period

    At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. Percentages have been rounded off.

    Measured: Cycle 6 Day 1 (Cycle length=21 days)

  3. Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area

    The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1-6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?"

    Measured: Day 1 of Cycles 1 to 6 (cycle length= 21 days)

  4. Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area

    HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Question 2 at Cycle 6 of Treatment Crossover Period for every participant: "If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a=Staff will have increased availability for other tasks in pharmacy; b=Administrative procedures around atezolizumab SC will require less time; c=Atezolizumab SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use atezolizumab SC formulations, potential dosing errors will be avoided; e=Due to ready-to-use atezolizumab SC formulations, there will be less drug wastage; f=Without having to reconstitute the drug, less storage space for atezolizumab SC related supplies will be required in pharmacy; g=Preparation procedures \& associated time staff time commitment will be reduced, h=It will ease drug administration for participants with difficult venous access."

    Measured: Cycle 6 Day 1 (cycle length=21 days)

  5. Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area

    HCPs who prepared study treatment within the pharmacy/drug preparation area responded at to the following HCPQ-Drug Preparation Area Questions 3 and 4, at Cycle 6 of the Treatment Crossover Period for every participant: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Question 4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Percentages have been rounded off.

    Measured: Cycle 6 Day 1 (cycle length= 21 days)

  6. Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room

    The HCPQ-Treatment Room Question 1 was completed for every participant at each treatment cycle of the Treatment Crossover Period (Cycles 1-6,i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC/vice versa) by HCPs who administered treatment to the study participants. HCPs responded to following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter (PICC)/peripheral vein cannulation) \& how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the participant in the treatment room for in total?" Durations with non-zero HCP responders have been reported here.

    Measured: Day 1 of Cycles 1 to 6 (cycle length=21 days)

  7. Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room

    HCPs who administered treatment responded to Question 2: If all IV are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a= Participants will be moved outside of infusion unit to receive SC injections (physician consultation room); b=Atezolizumab SC route will allow more flexible treatment scheduling; c=More participants will be treated in infusion unit; d=Waiting list for any IV treatment at infusion unit will be reduced; e=Staff resources will be re distributed to other departments of the hospital (less staffing required within infusion unit); f=There will still be sufficient interaction time between HCPs \& participants (for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by atezolizumab SC injection is preferred by participants.

    Measured: Cycle 6 Day 1 (cycle length=21 days)

  8. Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room

    HCPs who administered study treatment responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Which method was most convenient for the participant? Question 4. Which method was best for optimizing participant care in your center? Question 5. Which method took the least time from start to finish of administration? Question 6. Which method required the least resource use for administration? Question 7. Which method was preferred by participants?" The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Percentages have been rounded off.

    Measured: Cycle 6 Day 1 (cycle length=21 days)

  9. Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room

    HCPs who administered study treatment responded at Cycle 6 of the treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Percentages have been rounded off.

    Measured: Cycle 6 Day 1 (cycle length= 21 days)

  10. Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30)

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  11. Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  12. Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  13. Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  14. Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  15. Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  16. Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  17. Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  18. Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The dyspnoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  19. Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The insomnia scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  20. Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The appetite loss scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  21. Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The constipation scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  22. Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The diarrhoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  23. Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The financial difficulties scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  24. Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30

    EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/ QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and QoL (Q30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.

    Measured: Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years)

  25. Percentage of Participants With Ongoing Clinical Benefit

    Participants were assessed for clinical benefit at every tumour assessment visit, which was conducted as per the local standard of care. Percentages have been rounded off.

    Measured: Up to Cycle 16 (cycle length= 21 days)

  26. Percentage of Participants With Adverse Events (AEs)

    An AE is untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to the investigational product. Percentages have been rounded off.

    Measured: Up to 90 days after the final dose of study drug (Up to 2.4 years)

  27. Percentage of Participants With AEs During Treatment Cross-over Period

    An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure. Percentages have been rounded off.

    Measured: From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start4 Apr 2022
  3. Primary completion9 Nov 2023
  4. Study completion25 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171777
Sponsor's protocol ID
MO43576
Status last verified
Nov 2025
First submitted
29 Nov 2021
Last updated
11 Dec 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Felip E, Majem M, Korbenfeld E, Kolb-Sielecki J, Isla D, Barata T, Bustillos A, Herraez-Baranda LA, Tosti N, Young F, Zanghi J, Cappuzzo F. Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Lung Cancer. 2026 Jul;217:109452. doi: 10.1016/j.lungcan.2026.109452. Epub 2026 May 12.

    PubMed 42214243
  • Majem M, Chewaskulyong B, Zvirbule Z, Lee KH, Korbenfeld E, Kolb-Sielecki J, Castro Sanchez AY, Bustillos A, Herraez-Baranda L, Liu X, Kim SW, Cappuzzo F. Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. Oncol Ther. 2026 Mar;14(1):313-326. doi: 10.1007/s40487-025-00402-x. Epub 2025 Nov 26.

    PubMed 41296193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 36 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Spain, United States, Brazil, Finland, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) (time frame: Cycle 6 Day 1 (cycle length=21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05171777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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