A study of Daratumumab combined with Atezolizumab versus Atezolizumab in Previously Treated Subjects with Advanced Non-Small Cell Lung Cancer.
- Conditions
- Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 19.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002579-83-FR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
1. =18 years of age
2. ECOG performance status of 0 or 1.
3. Have histologically or cytologically confirmed advanced or metastatic NSCLC (Stage IIIb or IV).
4. Measurable disease, as defined by RECIST v1.1.
5. Known PD-L1 tumor status as determined by an IHC assay performed by the central laboratory on tissue obtained at Screening.
6. Specific laboratory results obtained within 14 days prior to first administration of study drug.
7. A woman of childbearing potential must have a negative highly sensitive serum (b-human chorionic gonadotropin [b-hCG]) at Screening within 14 days prior to study drug administration.
8. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
9. During the study and for a minimum of approximately 3 months after the last dose of daratumumab or 5 months after the last dose of atezolizumab, in addition to the highly effective method of contraception, a man
- who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository)
- who is sexually active with a woman who is pregnant must use a condom
- must agree not to donate sperm.
10. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
11. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
1. Received any of the following prescribed medications or therapies in the past:
- Anti-CD38 therapy, including daratumumab
- CD137 agonists, immune checkpoint inhibitors including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapies
2. Received any of the following prescribed medications or therapies within the specified period:
- Approved anti-cancer therapy, including chemotherapy, within 3 weeks prior to initiation of study treatment.
- Other investigational agent or participation in another clinical study with therapeutic intent within 28 days or 5 half-lives of the investigational agent (whichever is longer) to enrollment.
- Use of systemic corticosteroids =2 weeks before Cycle 1 Day 1.
- Use of systemic corticosteroids =10 mg/day prednisone equivalent, or acute use of higher equivalent doses may be allowed with Medical Monitor approval.
3. Has any of the following conditions:
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during Screening and prior radiographic assessments.
- Leptomeningeal disease or spinal cord compression not definitively treated with surgery or radiation
- Uncontrolled tumor-related pain
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); indwelling catheters are allowed.
5. Malignancies other than NSCLC within 2 years prior to randomization, with the exception of carcinoma in situ of the cervix or breast, basal or squamous-cell skin cancer, or other malignancy that in the opinion of the investigator and Sponsor’s Medical Monitor is considered cured with a minimal risk of recurrence within 5 years.
6. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
7. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), druginduced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
8. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
9. Known to be seropositive for human immunodeficiency virus (HIV)
10. Active hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive).
11. Severe infections (including active tuberculosis) within 1 week prior to initiation of study treatment, including but not limited to hospitalization
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