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AzTrials

Non-Small Cell Lung CancerPhase 3NCT05047250

A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

A Phase 3 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 18 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC. 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
60 participants
Where
18 sitesChina
Study dates
14 Jun 2022to 29 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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.
  • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC.
  • No prior treatment for Stage IV non-squamous or squamous NSCLC.
  • Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle.
  • Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
  • Measurable disease, as defined by RECIST v1.1.
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  • Adequate hematologic and end-organ function.
  • Life expectancy ≥3 months.
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating.

Who cannot join

  • Known sensitizing mutation in the EGFR gene or ALK fusion oncogene.
  • Symptomatic, untreated, or actively progressing CNS metastases.
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥2 weeks prior to enrollment.
  • Current leptomeningeal disease.
  • Uncontrolled tumor-related pain.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
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  • Uncontrolled or symptomatic hypercalcemia.
  • Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
  • Active or history of autoimmune disease or immune deficiency.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Positive human immunodeficiency virus (HIV) test result at screening.
  • Patients with active hepatitis B or active hepatitis C at screening.
  • Active tuberculosis.
  • Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Significant cardiovascular disease.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, 100050

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

  • Beijing Chest Hospital

    Beijing, 101149

  • The Third Xiangya Hospital Of Central South University

    Changsha, 410013

  • Daping Hospital of Third Military Medical University

    Chongqing, 400042

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

  • Anhui Province Cancer Hospital

    Hefei, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Linyishi Cancer Hospital

    Linyi, 276034

  • Nanjing Chest Hospital

    Nanjing, 210029

  • Shanghai Chest Hospital

    Shanghai, 200000

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430023

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

Other trials in China

About this study

Official title: A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

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 by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Study groups in NCT05047250
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive IV infusion of atezolizumab on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.
Receives: Drug: Atezolizumab

What is being measured

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

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.

    Measured: Atezolizumab initiation to death from any cause (up to approximately 28 months)

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by investigators according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

    Measured: Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months)

  2. OS Rate at 1-Year

    OS rate at 1-year is defined as the probability of participants who have not experienced death from any cause at 1-year after atezolizumab initiation.

    Measured: Atezolizumab initiation to 1-year

  3. OS Rate at 2-Year

    OS rate at 2-year is defined as the probability of participants who have not experienced death from any cause at 2-year after atezolizumab initiation.

    Measured: Atezolizumab initiation to 2-year

  4. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR), as determined by investigators according to RECIST v1.1.

    Measured: Randomization up to approximately 34 months

  5. Duration of Response (DOR)

    Duration of response (DOR) is defined as the time from the first occurrence of an objective response to disease progression or death from any cause (whichever occurs first), as determined by investigators according to RECIST v1.1.

    Measured: Randomization up to approximately 34 months

  6. Percentage of Participants With Adverse Events

    Percentage of participants with adverse events.

    Measured: Randomization up to approximately 34 months

Timeline

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

  1. First posted17 Sep 2021
  2. Study start14 Jun 2022
  3. Primary completion30 Dec 2025
  4. Study completion29 Jan 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047250
Sponsor's protocol ID
ML42606
Status last verified
Sep 2026
First submitted
8 Sep 2021
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 18 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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Overall survival (OS) (time frame: Atezolizumab initiation to death from any cause (up to approximately 28 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 NCT05047250.

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 30 Sep 2026.

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