A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab IV in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Atezolizumab; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically documented locally advanced or metastatic NSCLC

• Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen.

• Measurable disease as defined by RECIST v1.1

• ECOG Performance Status of 0 or 1

• Life expectancy ≥12 weeks

• Adequate hematologic and end-organ function

Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known EGFR status

Exclusion Criteria:

• Symptomatic, untreated, or actively progressing CNS metastases

• Uncontrolled or symptomatic hypercalcemia

• Pregnancy or breastfeeding

• Active or history of autoimmune disease or immune deficiency

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

• Severe infection ≤ 4 weeks

• Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment

• Significant cardiovascular disease

• Prior allogeneic stem cell or solid organ transplantation

• Treatment with a live, attenuated vaccine ≤ 4 weeks

• Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug

• Treatment with systemic immunosuppressive medication ≤ 2 weeks

Additional Exclusion Criteria (Part 2 Only)

• Tested tumor PD-L1 expression status with an intention to treat the patient if positive