Evaluating atezolizumab for advanced lung cancer patients without prior chemotherapy

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 study is testing if atezolizumab can help people with advanced lung cancer who haven't had chemotherapy yet feel better and improve their health.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hoffmann-La Roche (Industry-sponsored)
• Drugs / interventions: atezolizumab, chemotherapy, radiation
• Locations: 27 sites (Beijing City and 26 other locations)
• Trial ID: NCT05047250 on ClinicalTrials.gov

What this trial studies

This Phase III, single-arm, multicenter study aims to assess the efficacy and safety of atezolizumab in patients with high PD-L1 expression who have not received prior chemotherapy for stage IV non-squamous or squamous non-small cell lung cancer (NSCLC). Eligible participants must have measurable disease and specific tumor characteristics, and they will be monitored for treatment outcomes. The study focuses on a targeted patient population to determine the potential benefits of atezolizumab as a treatment option.

Who should consider this trial

Good fit: Ideal candidates are chemotherapy-naïve patients with stage IV non-squamous or squamous NSCLC and high PD-L1 expression.

Not a fit: Patients with known sensitizing mutations or those who have previously received treatment for stage IV NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with atezolizumab in similar patient populations, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing City and 26 other locations

• Xuanwu Hospital, Capital Medical University — Beijing City, China (Active_not_recruiting)
• Beijing Tiantan Hospital,Capital Medical University — Beijing, China (Recruiting)
• Beijing Chest Hospital — Beijing, China (Recruiting)
• The Third Xiangya Hospital Of Central South University — Changsha, China (Recruiting)
• Changzhou First People's Hospital — Changzhou, China (Recruiting)
• Sichuan Cancer Hospital — Chengdu City, China (Withdrawn)
• Daping Hospital of Third Military Medical University — Chongqing, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, China (Withdrawn)
• Sir Run Run Shaw Hospital Zhejiang University — Hangzhou City, China (Active_not_recruiting)
• The Second Affiliated Hospital, Zhejiang University — Hangzhou, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Withdrawn)
• Anhui Province Cancer Hospital — Hefei City, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Shandong Cancer Hospital — Jinan, China (Withdrawn)
• The First Affiliated Hospital Of Jinzhou Medical University — Jinzhou City, China (Recruiting)
• Yunnan Cancer Hospital — Kunming City, China (Recruiting)
• Linyishi Cancer Hospital — Linyi City, China (Recruiting)
• Nanjing Chest Hospital — Nanjing City, China (Recruiting)
• Jiangsu Cancer Hospital — Nanjing City, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, China (Recruiting)
• Cancer Hospital of Shantou University Medical College — Shantou, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, China (Recruiting)
• Tianjin Cancer Hospital — Tianjin, China (Recruiting)
• Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• Renmin Hospital of Wuhan University — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: ML42606 https://forpatients.roche.com/

Conditions Non-Small Cell Lung Cancer