Carcinoma, Non-Small-Cell LungPhase 2NCT04426825
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 10 sites in China.
Trial summary
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Atezolizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesChina
- Study dates
- 9 Sep 2020to 10 Feb 2023
- 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
- Life expectancy ≥ 10 months
- Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
- No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:
- Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.
- Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.
- Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.
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- TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment.
- Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- ECOG Performance Status of 0-1
- Adequate hematologic and end-organ function
- Negative HIV test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Who cannot join
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- History of leptomeningeal disease
- Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
- 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
- Active tuberculosis
Show all 32Show fewer
- Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
- Current treatment with anti-viral therapy for HBV
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab
- Prior history of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease within 6 months prior to initiation of study treatment
- History of Grade ≥ 2 hemoptysis within 1 month prior to enrollment
- Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol
- Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to enrollment
- History of stroke or transient ischemic attack within 6 months prior to enrollment
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
- History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment
- History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis
- Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Proteinuria
- Clear tumor infiltration into the thoracic great vessels is seen on imaging
- Clear cavitation of pulmonary lesions is seen on imaging
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Cancer Hospital
Beijing, 100142
Beijing Hospital; Internal Medicine-Oncology
Beijing, 100730
Beijing Chest Hospital; Oncology Department
Beijing, 101149
West China Hospital, Sichuan University
Chengdu, 610041
Sun Yet-sen University Cancer Center
Guangzhou, 510663
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
Shandong Cancer Hospital
Jinan, 250117
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266000
About this study
Official title: A Single Arm, Phase II Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Pretreated With Epidermal Growth Factor Receptor Tyrosine-Kinase Inhibitors
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Atezolizumab, Bevacizumab
- 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 at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab plus Bevacizumab | Experimental | Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death. Receives: Drug: Atezolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Measured: Baseline up to approximately 10 months
Secondary outcomes (17)
Duration of Objective Response (DOR)
Duration of objective response (DOR) was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.
Measured: Baseline up to approximately 2.5 years
Time to Response (TTR)
Time to response (TTR) was defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
Measured: Baseline up to approximately 2.5 years
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
Measured: Baseline up to approximately 2.5 years
Overall Survival (OS)
OS after enrollment was defined as the time from enrollment to death from any cause.
Measured: Baseline until death due to any cause (up to approximately 2.5 years)
Progression-Free Survival (PFS)
Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Measured: Baseline up to approximately 2.5 years
PFS Rate at 6 and 12 Months
PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.
Measured: Baseline to 6 months and 12 months
OS Rate at 1 and 2 Years
OS rate at 1 and 2 years was defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.
Measured: Baseline to 1 and 2 Years
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Measured: Baseline up to approximately 2.5 years
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)
Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment. The AESIs were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. The grading is as follows: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.
Measured: Baseline up to approximately 2.5 years
Objective Response Rate (ORR) According to iRECIST
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).
Measured: Baseline up to approximately 2.5 years
Disease Control Rate (DCR) According to iRECIST
Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Measured: Baseline up to 2 years and approximately 5 months
Duration of Objective Response (DOR) According to iRECIST
Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Measured: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) According to iRECIST
Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Measured: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST
Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Measured: Baseline up to approximately 12 months
Time to Deterioation (TTD) Using EORTC
Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a >=10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnoea (single item), dyspnoea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurred first. Scores ranged from 0-10. A higher score represented more severe symptoms.
Measured: Baselsine up to approximately 1 year
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status
The 30-item EORTC QLQ-C30 version 3 is composed by five multi-item function scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), and a two-item global quality of life scale. All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for the functional and general health areas represent better functional status and quality of life. Higher scores for the symptom scales represent more symptoms or problems (poor quality of life). A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.
Measured: Baseline up to approximately 1 year
Change From Baseline in Lung Cancer Related Symptoms
The EORTC QLQ-LC13 is a specific module for lung cancer. It consists of 13 items covering lung cancer symptoms (dyspnoea, coughing, hemoptysis, pain in chest, pain in arm or shoulder and pain in other parts) and the side effects of chemo- and radiotherapy (alopecia, peripheral neuropathy, sore mouth, and dysphagia), which are divided into 10 fields, all are symptom types. All EORTC symptom scores are linearly transformed so that each score has a range of 0-100. A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.
Measured: Baseline up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start9 Sep 2020
- Primary completion19 Jan 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426825
- Sponsor's protocol ID
- ML41256
- Status last verified
- May 2024
- First submitted
- 9 Jun 2020
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical 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
Fang W, Fang J, Tian P, Fan Y, Yu Q, Zhang X, Wang Z, Liu X, Shi Y, Zhang L. Efficacy and Safety of Atezolizumab Plus Bevacizumab in Patients With Advanced NSCLC Who Received Pretreatment With EGFR-TKIs (ML41256): A Multicenter, Prospective, Single-Arm, Phase 2 Trial. Cancer Med. 2025 Dec;14(24):e71469. doi: 10.1002/cam4.71469.
PubMed 41388935
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Phase II Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Pretreated With Epidermal Growth Factor Receptor Tyrosine-Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT04426825
- Acronym / sponsor ID
- ML41256
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab plus Bevacizumab | Experimental | Drug: Atezolizumab, Drug: BevacizumabParticipants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Life expectancy ≥ 10 months
- Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
- No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:
- Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.
- Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.
Key exclusion criteria (32 listed)
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- History of leptomeningeal disease
- Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqAtezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle. | Drug | Atezolizumab plus Bevacizumab |
| BevacizumabAlso: AvastinBevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle. | Drug | Atezolizumab plus Bevacizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline up to approximately 10 months
Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
17 secondary outcomes
Duration of Objective Response (DOR)
Time frame: Baseline up to approximately 2.5 years
Time to Response (TTR)
Time frame: Baseline up to approximately 2.5 years
Disease Control Rate (DCR)
Time frame: Baseline up to approximately 2.5 years
Overall Survival (OS)
Time frame: Baseline until death due to any cause (up to approximately 2.5 years)
Progression-Free Survival (PFS)
Time frame: Baseline up to approximately 2.5 years
PFS Rate at 6 and 12 Months
Time frame: Baseline to 6 months and 12 months
OS Rate at 1 and 2 Years
Time frame: Baseline to 1 and 2 Years
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 2.5 years
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)
Time frame: Baseline up to approximately 2.5 years
Objective Response Rate (ORR) According to iRECIST
Time frame: Baseline up to approximately 2.5 years
Disease Control Rate (DCR) According to iRECIST
Time frame: Baseline up to 2 years and approximately 5 months
Duration of Objective Response (DOR) According to iRECIST
Time frame: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) According to iRECIST
Time frame: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST
Time frame: Baseline up to approximately 12 months
Time to Deterioation (TTD) Using EORTC
Time frame: Baselsine up to approximately 1 year
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status
Time frame: Baseline up to approximately 1 year
Change From Baseline in Lung Cancer Related Symptoms
Time frame: Baseline up to approximately 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41388935Fang W, Fang J, Tian P, Fan Y, Yu Q, Zhang X, Wang Z, Liu X, Shi Y, Zhang L. Efficacy and Safety of Atezolizumab Plus Bevacizumab in Patients With Advanced NSCLC Who Received Pretreatment With EGFR-TKIs (ML41256): A Multicenter, Prospective, Single-Arm, Phase 2 Trial. Cancer Med. 2025 Dec;14(24):e71469. doi: 10.1002/cam4.71469.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 10 sites in China.
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 16 inclusion and 32 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 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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 13 Apr 2023). 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?
Objective Response Rate (ORR) (time frame: Baseline up to approximately 10 months). 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 NCT04426825, which also lists 1 linked publication.
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 21 May 2024.