Trial record 1 of 1 for:
MO43576
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
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| ClinicalTrials.gov Identifier: NCT05171777 |
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Recruitment Status :
Recruiting
First Posted : December 29, 2021
Last Update Posted : January 26, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief 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 IIB-IIIB (early-stage) 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Atezolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 4, 2022 |
| Estimated Primary Completion Date : | July 15, 2023 |
| Estimated Study Completion Date : | March 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment A
Participants will receive atezolizumab SC followed by atezolizumab IV.
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Drug: Atezolizumab
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.
Other Name: Tecentriq |
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Experimental: Treatment B
Participants will receive atezolizumab IV followed by atezolizumab SC.
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Drug: Atezolizumab
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.
Other Name: Tecentriq |
Primary Outcome Measures :
- Proportion of Participants Who Preferred Atezolizumab SC to Atezolizumab IV [ Time Frame: Following treatment administration on Day 1 of Cycle 6 (cycle length is 21 days) of the Treatment Cross-over Period ]Proportion of participants who preferred atezolizumab SC to atezolizumab IV, with treatment preference assessed using Question 1 of the Patient Preference Questionnaire (PPQ).
Secondary Outcome Measures :
- Participant-Reported Satisfaction With Atezolizumab SC and Atezolizumab IV [ Time Frame: Following treatment administration on Day 1 of Cycles 3 and 6 (cycle length is 21 days) of the Treatment Cross-over Period ]Evaluate participant-reported satisfaction with atezolizumab SC and atezolizumab IV assessed using Question 1 of the Therapy Administration Satisfaction Questionnaire - subcutaneous (TASQ-SC) and TASQ - intravenous (TASQ-IV).
- Proportion of Participants Who Select Atezolizumab SC [ Time Frame: After Cycle 6 (Cycle length is 21 days) ]Evaluate participants' choice of atezolizumab SC for the Treatment Continuation Period based on the proportion of participants who select atezolizumab SC for this study period
- HCP Perception of Time/Resource Use With Atezolizumab SC Compared to Atezolizumab IV [ Time Frame: During Treatment Cross-over Period (3+3 cycles; each cycle is 21days) ]Evaluate HCP perception of time/resource use with atezolizumab SC compared to IV based on HCP responses to the Healthcare Professional Questionnaires (HCPQs), by individual question.
- HCP Perception of Convenience for Administration With Atezolizumab SC Compared to Atezolizumab IV [ Time Frame: After administration of each participant's treatment Cycle 6 (cycle length is 21 days) ]Evaluate HCP perception of convenience for administration with atezolizumab SC and IV based on HCP responses to the Healthcare Professional Questionnaires (HCPQs), by individual question.
- Change in Symptoms, as Assessed by EORTC QLQ-C30 Scores [ Time Frame: Baseline and over time (through approximately 2 years) ]Change in symptoms from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) scores.
- Change in Function, as Assessed by EORTC QLQ-C30 Scores [ Time Frame: Baseline and over time (through approximately 2 years) ]Change in function from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) scores.
- Changes in Score in HRQoL [ Time Frame: Baseline and over time (through approximately 2 years) ]Changes from baseline score in HRQoL by cycle as assessed by the Global Health Status/Quality of Life (GHS/QoL) scale (items 29 and 30) of the EORTC QLQ-C30.
- Percentage of Participants With Continuing Clinical Benefit [ Time Frame: After Cycle 16 (each cycle is 21 days) ]Percentage of participants with continuing clinical benefit after 16 cycles of atezolizumab, as assessed by the investigator according to local standard of care.
- Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 2 years ]
- Percentage of Participants With Adverse Events During Treatment Cross-over Period [ Time Frame: During the study Treatment Cross-over Period (3+3 cycles; each cycle is 21days) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria for All Participants:
- ECOG performance status of 0 or 1
Inclusion Criteria for Participants with Early-stage NSCLC:
- Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-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 therapy
Inclusion Criteria for Participants with Stage IV NSCLC:
- Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
- Life expectancy ≥ 18 weeks in the opinion of the investigator
- 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.
Exclusion Criteria for All Participants:
- 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
- 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
Exclusion Criteria for Participants with Stage IV NSCLC:
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05171777
Contacts
| Contact: Reference Study ID Number: MO43576 https://forpatients.roche.com/ | 888-662-6728 (U.S. and Canada) | global.rochegenentechtrials@roche.com |
Locations
Show 50 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT05171777 |
| Other Study ID Numbers: |
MO43576 |
| First Posted: | December 29, 2021 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Atezolizumab Antineoplastic Agents |