A Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared with Atezolizumab Intravenous in Patients with Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- on-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002328-18-HU
- Lead Sponsor
- F. Hoffman-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 387
Applicable to both Parts 1 and 2
- Age >=18 years
- Ability to comply with the study protocol, in the investigator's judgment
- Measurable disease as defined by RECIST v1.1
- Eastern cooperative oncology group performance status of 0 or 1
- Life expectancy >=12 weeks
- Adequate hematologic and end-organ function
- Negative HIV test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- Negative hepatitis C virus (HCV) antibody test, or positive HCV antibody test followed by a negative HCV RNA test at screening
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggsduring the treatment period and for 5 months after the final dose of atezolizumab and for 6 months after the last dose of bevacizumab, carboplatin, or paclitaxel
- Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia
- Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection in the thighs
- For patients randomized in the extended China enrollment phase at qualified sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Additional inclusion criteria applicable to Part 1 only
- A body mass index between 18 and 32 kg/m2 inclusive
Additional inclusion criteria applicable to Part 2 only
- For patients whose tumor may harbor a sensitizing EGFR mutation, known EGFR test results at the time of randomization
- Availability of a pre-study treatment representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or at least six slides, from an FFPE tumor specimen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 172
Applicable to both Parts 1 and 2
- 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
- History of leptomeningeal disease
- Uncontrolled pleural effusion or symptomatic hypercalcemia, pericardial effusion, or ascites requiring recurrent drainage procedures
- History of malignancy other than NSCLC within 5 years prior to screening
- History of severe anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or any component of the atezolizumab formulation
- Active or history of autoimmune disease or immune deficiency or tuberculosis
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- Current treatment with anti-viral therapy for HBV
- Severe infection within 4 weeks prior to initiation of study treatment
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Significant cardiovascular disease, within 3 months prior to initiation of study treatment
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, or that may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Related to Medications
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug and systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
- Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20
Applicable to Part 1 Only
- Pathology that could interfere with any protocol-specified outcome assessment
Applicable to Part 2 Only
- Tested tumor PD-L1 expression status with an intention to treat the patient if positive
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method