A Study of MTIG7192A in Combination with Atezolizumab in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- ocally advanced or metastatic non-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 10059515Term: Non-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
- EUCTR2018-000280-81-PL
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 135
- Age >= 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC
- No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
- Tumor PD-L1 expression on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Confirmed availability of representative tumor specimens, along with an associated pathology report.
- Measurable disease as defined by RECIST v1.1
- Life expectancy >=12 weeks
- Adequate hematologic and end-organ function
- For women of childbearing potential: Women must remain abstinent or use contraceptive methods during the treatment period and for at least 5 months after the last dose of study drugs
- For men: men must remain abstinent or use a condom during the treatment period and for at least 90 days after the last dose of study treatment
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- Patients with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- Symptomatic, untreated,, or actively progressing CNS metastases
- Spinal cord compression not definitively treated with surgery and/or radiation
- History of leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia 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 and/or treated with expected curative outcome
General Medical Exclusions
- Inability to comply with study and/or follow-up procedures
- Pregnant, lactating, or breastfeeding women
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
- Known clinically significant liver disease or current alcohol abuse
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to initiation of study treatment
- Received oral or IV antibiotics (including antifungals) within 2 weeks prior to randomization
- Major surgical procedure within 4 weeks prior to randomization, or anticipation of need for a major surgical procedure during the study
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications
Treatment-Specific Exclusions
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to CHO cell products or any component of the atezolizumab formulation
- Active or history of autoimmune disease
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- History of idiopathic pulmonary fibrosis (including pneumonitis), organizing pneumonia drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- Positive test for HIV at screening
- Patients with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
- Patients with active Epstein-Barr virus (EBV) infection and patients with known or suspected chronic active EBV infection
- Active tuberculosis
- Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization
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