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

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Atezolizumab; Drug: rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT03735121

2018-002328-18 (EudraCT Number)

BP40657

Details and patient eligibility

About

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Eastern Cooperative Oncology Group (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 epidermal growth factor receptor (EGFR) status

Exclusion criteria

• Symptomatic, untreated, or actively progressing central nervous system (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 programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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438 participants in 5 patient groups

Atezolizumab (Part 2)

Experimental group

Description:

Atezolizumab

Treatment:

Drug: Atezolizumab

Cohort 1: Atezolizumab+rHuPH20 (Part 1)

Experimental group

Description:

Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab

Treatment:

Drug: rHuPH20

Drug: Atezolizumab

Cohort 2: Atezolizumab+rHuPH20 (Part 1)

Experimental group

Description:

Atezolizumab+rHuPH20, followed by Atezolizumab

Treatment:

Drug: rHuPH20

Drug: Atezolizumab

Cohort 3: Atezolizumab+rHuPH20(Part 1)

Experimental group

Description:

Atezolizumab+rHuPH20, followed by Atezolizumab

Treatment:

Drug: rHuPH20

Drug: Atezolizumab

Atezolizumab + rHuPH20 (Part 2)

Experimental group

Description:

Atezolizumab + rHuPH20

Treatment:

Drug: rHuPH20

Drug: Atezolizumab