A Phase III, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Platinum Doublet Chemotherapy for PD-L1 Highly Expressed, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

  • End date
    Jun 30, 2025
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 21 October 2022
measurable disease
cancer chemotherapy
adjuvant chemotherapy
platinum-based chemotherapy
platinum doublet
lung carcinoma
squamous non-small cell lung cancer


This is a Phase III, randomized study to evaluate the efficacy and safety of atezolizumab compared with platinum-based chemotherapy consisting of a platinum agent (carboplatin or cisplatin) in combination with pemetrexed (non-squamous disease) OR gemcitabine or paclitaxel (squamous disease) in highly PD-L1 expressed, chemotherapy-naïve, EGFR/ALK wild type patients with stage IV non-squamous or squamous NSCLC.

Condition Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Gemcitabine, Paclitaxel, Pemetrexed, Atezolizumab
Clinical Study IdentifierNCT05047250
SponsorHoffmann-La Roche
Last Modified on21 October 2022


Yes No Not Sure

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 randomization 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
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm

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 randomization
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 randomization, 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 and 6 months for chemotherapy
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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