A Study of Atezolizumab 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

• Status: Not yet recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Atezolizumab; Carboplatin; Gemcitabine; Paclitaxel; Pemetrexed

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 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.