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New hope for lung cancer: immunotherapy without chemo shows promise

NCT ID NCT05047250

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This phase III trial is testing the immunotherapy drug atezolizumab (Tecentriq) in 60 people with advanced non-small cell lung cancer that has high PD-L1 levels and has not been treated before. Participants receive the drug every three weeks. The study aims to see if it helps them live longer and controls the cancer, while monitoring side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (Tecentriq)
What this could lead to
If successful, this could provide a new first-line treatment option for people with advanced lung cancer who have high PD-L1 levels, potentially improving survival without chemotherapy.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. The drug may not work for everyone and can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Anhui Province Cancer Hospital

    Hefei, 230001, China

  • Beijing Chest Hospital

    Beijing, 101149, China

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, 100050, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041, China

  • Daping Hospital of Third Military Medical University

    Chongqing, 400042, China

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Linyishi Cancer Hospital

    Linyi, 276034, China

  • Nanjing Chest Hospital

    Nanjing, 210029, China

  • Renmin Hospital of Wuhan University

    Wuhan, 430060, China

  • Shanghai Chest Hospital

    Shanghai, 200000, China

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • The Third Xiangya Hospital Of Central South University

    Changsha, 410013, China

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

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

    Wuhan, 430023, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053, China

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