Atezolizumab

Clinical trials investigating Atezolizumab are studying how well it works in different cancers and other medical settings. These studies look at safety, efficacy, and study measures like survival, recurrence, and response to treatment. The target groups include patients with lung cancer, liver cancer, breast cancer, bladder cancer, mesothelioma, lymphoma, and other solid tumors.

Table of Contents

Trial overview

These clinical trials study Atezolizumab in many different cancer settings, often with other treatments such as chemotherapy, bevacizumab, tiragolumab, radiation, or surgery.[1] The studies look at both how well treatment works and how safe it is in real patient groups.[2] Many trials are in advanced cancer, but some are in earlier stages or after surgery.[3]

Several trials compare Atezolizumab with placebo, standard treatment, or another immunotherapy.[4][5] Other trials test Atezolizumab as part of a combination plan, such as with chemotherapy, targeted therapy, or radiation.[6]

Who can join these studies

The target population changes from trial to trial.[7] Some studies include adults with advanced or metastatic cancer, while others focus on people with resectable disease, meaning the tumor can be removed by surgery.[1] Some trials also focus on special groups, such as patients after chemotherapy and radiotherapy, patients after cystectomy, or patients with high-risk disease after surgery.[4]

There are also studies for specific groups such as pediatric and adult patients with soft tissue sarcoma, elderly patients with non-small cell lung cancer, and patients with liver transplant and recurrent hepatocellular carcinoma.[7][8] Some trials use biomarker selection, which means the study looks for a tumor feature or blood marker before deciding who can join.[9]

Study phases and what they mean

The trial data includes Phase 1, Phase 2, Phase 3, and a few combined phases such as Phase 1/2 or Phase 2/3.[1] Phase 1 studies usually focus on safety, dose, and the first signs of effect.[10] Phase 2 studies usually look at early effectiveness and sometimes safety in a smaller group.[2] Phase 3 studies are larger and often compare Atezolizumab with another treatment, placebo, or standard care.[4]

Some trials also include extension or rollover studies, which are designed to let eligible patients continue treatment after a parent study ends.[11] These studies are not mainly about finding a new effect; they are about continued access and follow-up.[12]

What the trials measure

Many trials use survival outcomes such as overall survival, progression-free survival, disease-free survival, and recurrence-free survival.[1] These measures show whether people live longer, whether the cancer stays controlled, or whether it comes back after treatment.[13]

Other common endpoints are objective response rate, pathological complete response, and major pathological response.[14] These tell researchers how much the tumor shrinks or how much cancer remains in tissue after treatment or surgery.[15] Safety is also a major endpoint in many studies, especially in early-phase trials and combination studies.[2]

Main cancer areas studied

Lung cancer is one of the most common areas studied, including non-small cell lung cancer and small cell lung cancer, in both newly diagnosed and previously treated patients.[16] Several studies test Atezolizumab with chemotherapy, tiragolumab, bevacizumab, radiation, or maintenance treatment after induction therapy.[17]

Liver cancer, especially hepatocellular carcinoma, is another major focus.[18] Trials include first-line treatment, neoadjuvant and adjuvant treatment, post-surgery treatment, and studies in unresectable disease or in patients at high risk of recurrence.[3]

Breast cancer trials include triple-negative breast cancer, HER2-positive breast cancer, and metastatic breast cancer.[2] Some studies examine Atezolizumab with chemotherapy, while others test it with targeted or immune-based combinations.[19]

Other important areas include bladder cancer, mesothelioma, colorectal cancer, lymphoma, melanoma, head and neck cancer, sarcoma, prostate cancer, and cervical cancer.[4] In several of these studies, Atezolizumab is tested after surgery, after chemoradiotherapy, or in patients whose disease has come back or spread.[14]

Special study types and research questions

Some trials are designed to test a new combination, such as Atezolizumab with another immune treatment, chemotherapy, or radiotherapy.[5] Others compare Atezolizumab against standard treatment, placebo, or active surveillance to see which option gives better results.[4]

A few studies are not focused mainly on treatment effect in the usual way. For example, some trials look at imaging with labeled Atezolizumab, skin testing for allergy workups, or blood markers linked to immune toxicity.[20] These studies help researchers learn more about how to select patients, monitor response, or understand treatment reactions.[21]

Simple explanation of key trial terms

Adjuvant treatment means treatment given after the main treatment, often after surgery, to lower the risk that cancer returns.[13] Neoadjuvant treatment means treatment given before surgery to shrink the tumor or improve the chance of a good surgical result.[1]

Maintenance treatment means treatment that continues after the first treatment phase to help keep the disease under control.[14] Randomized means people are assigned by chance to different study groups, so the groups can be compared fairly.[4] Open-label means the treatment assignment is known in the study.[22]

Biomarker-driven means the trial uses a tumor feature, blood feature, or genetic result to guide treatment choice.[23] Histology means the type of cancer cells seen under a microscope, and RECIST is a standard way to measure tumor response on scans.[14]

Trial ID Phase Condition studied Status Enrollment
2024-519286-21-00Phase 3Malignant pleural mesotheliomaAuthorised90
2024-519514-31-00Phase 2Metastatic triple-negative PD-L1 positive breast cancerAuthorised104
NCT06646276Phase 3Extensive-stage small cell lung cancerAuthorised530
2024-515984-68-00Phase 2Non-small cell lung cancerAuthorised97
2024-516737-12-00Phase 2Unresectable hepatocellular carcinomaCompleted90
NCT07018947Phase 2Resectable hepatocellular carcinomaAuthorised90
2022-501217-31-00Phase 4Hepatocellular carcinomaAuthorised574
NCT03463057Phase 2High risk diffuse large B-cell lymphomaAuthorised109
2022-502705-15-00Phase 3High-risk muscle-invasive bladder cancerAuthorised247
2023-503756-27-00Phase 2Locally advanced unresectable stage III NSCLCCompleted130
2023-506632-32-00Phase 3Metastatic colorectal cancerAuthorised238
NCT05224141Phase 3Extensive-stage small-cell lung cancerAuthorised450
2024-517785-42-00Phase 3Renal cell carcinomaCompleted292
2024-514604-14-00Phase 2Muscle-invasive bladder cancerAuthorised39
2025-520565-51-00Phase 3Small cell lung cancerAuthorised674

Ongoing Clinical Trials on Atezolizumab

  • A study of pumitamig and ipilimumab in patients with advanced or unresectable liver cancer

    Recruiting

    1 1 1 1
    France Germany Italy Poland Spain
  • A study of PF-08634404 and a drug combination for adult patients with extensive-stage small cell lung cancer

    Recruiting

    4 1 1 1
    France Germany Italy Spain
  • A study of ABBV-706 and atezolizumab for patients with previously untreated extensive stage small cell lung cancer

    Recruiting

    2 1 1 1
    Belgium Germany Italy Poland Spain
  • A study of YL201 and atezolizumab for patients with advanced solid tumors

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +2
  • Study of BNT327 with etoposide and carboplatin compared to atezolizumab with etoposide and carboplatin for patients with untreated extensive-stage small-cell lung cancer

    Recruiting

    3 1 1 1
    France Germany Italy The Netherlands Poland Romania +1
  • Study of Heart and Blood Vessel Side Effects in Cancer Patients Receiving Immune Checkpoint Inhibitor Drug Combination Treatment

    Recruiting

    3 1 1 1
    Hungary
  • Testing zongertinib compared to standard treatment in patients with early-stage non-small cell lung cancer with HER2 mutations after surgery

    Recruiting

    3 1 1 1
    Investigated diseases:
    Austria Belgium Denmark France Germany Greece +6
  • A Study of Atezolizumab and Bevacizumab Before and After Surgery in Patients with Liver Cancer at High Risk of Coming Back

    Recruiting

    2 1 1 1
    Investigated drugs:
    Spain
  • Study of Rilvegostomig with Bevacizumab and Tremelimumab as First-line Treatment for Patients with Advanced Liver Cancer

    Recruiting

    3 1 1 1
    France Germany Italy The Netherlands Poland Spain
  • Comparing tarlatamab with standard chemotherapy in patients with pre-treated advanced pulmonary or gastroenteropancreatic neuroendocrine carcinomas

    Recruiting

    3 1 1 1
    France

Glossary

  • Phase: A stage of a clinical trial. Early phases usually look at safety and dose, while later phases compare how well treatments work.
  • Enrollment: The number of people planned for or included in a trial.
  • Overall survival (OS): How long people live after joining the study.
  • Progression-free survival (PFS): The length of time during which the cancer does not get worse.
  • Disease-free survival (DFS): The time after treatment when no cancer comes back or is found again.
  • Recurrence-free survival (RFS): The time after treatment when the cancer does not return.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • Pathological complete response (pCR): No visible cancer is found in tissue removed during surgery.
  • Major pathological response (MPR): A strong tumor response seen in tissue after treatment, usually meaning very little cancer remains.
  • Randomized: People are assigned by chance to different treatment groups.
  • Open-label: Both the study team and sometimes the patient know which treatment is being given.
  • Placebo: A look-alike treatment that does not contain the active study medicine.

References

  1. https://clinicaltrials.gov/study/2024-519286-21-00
  2. https://clinicaltrials.gov/study/2024-519514-31-00
  3. https://clinicaltrials.eu/trial/a-study-of-atezolizumab-and-bevacizumab-before-and-after-surgery-in-patients-with-liver-cancer-at-high-risk-of-coming-back/
  4. https://clinicaltrials.gov/study/2022-502705-15-00
  5. https://clinicaltrials.gov/study/2022-502482-17-00
  6. https://clinicaltrials.gov/study/2022-501217-31-00
  7. https://clinicaltrials.gov/study/2024-510712-75-00
  8. https://clinicaltrials.eu/trial/study-of-atezolizumab-carboplatin-and-paclitaxel-for-elderly-patients-with-advanced-non-small-cell-lung-cancer/
  9. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-tepotinib-and-drug-combination-for-patients-with-advanced-cancer/
  10. https://clinicaltrials.eu/trial/study-of-lb-100-and-atezolizumab-for-patients-with-metastatic-colorectal-cancer/
  11. https://clinicaltrials.gov/study/2023-506186-57-00
  12. https://clinicaltrials.gov/study/2023-504263-16-00
  13. https://clinicaltrials.gov/study/2023-504303-86-00
  14. https://clinicaltrials.gov/study/2023-503756-27-00
  15. https://clinicaltrials.eu/trial/study-on-atezolizumab-and-radiotherapy-for-patients-with-localized-operable-soft-tissue-sarcomas/
  16. https://clinicaltrials.eu/trial/study-comparing-bms-986489-with-chemotherapy-to-atezolizumab-with-chemotherapy-for-first-line-treatment-in-patients-with-extensive-stage-small-cell-lung-cancer/
  17. https://clinicaltrials.eu/trial/study-of-mk-7684a-etoposide-and-platinum-drugs-for-patients-with-extensive-stage-small-cell-lung-cancer/
  18. https://clinicaltrials.gov/study/2024-516737-12-00
  19. https://clinicaltrials.gov/study/2022-501561-51-00
  20. https://clinicaltrials.gov/study/2024-519812-15-00
  21. https://clinicaltrials.eu/trial/pet-imaging-with-89zr-atezolizumab-in-patients-with-large-b-cell-lymphoma-undergoing-cd19-car-t-cell-therapy/
  22. https://clinicaltrials.gov/study/2022-502052-30-00
  23. https://clinicaltrials.eu/trial/study-on-targeted-cancer-treatment-using-axitinib-and-avelumab-for-patients-with-advanced-cancer/