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: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002579-83-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- 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 greater).
4. Measurable disease, as defined by RECIST 1.1.
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 first administration of study drug.
- 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) prior to first administration of study drug.
-Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug.
-Use of systemic corticosteroids >10 mg/day prednisone equivalent within 14 days prior to first administration of study drug.
3. Has any of the following conditions:
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation.
- Leptomeningeal disease or spinal cord compression not definitively treated with surgery or
radiation, or requiring corticosteroid treatment at first administration of study drug.
- 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 first administration of study drug, 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 is considered cured with a minimal risk of recurrence within 5 years.
6. History of autoimmune disease.
7. History of pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced 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 spirometry is required during the screening
period 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 prior
history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc],
regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of
hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR),
defined as aviremia 12 weeks after completion of antiviral therapy.
11. Severe infections (including active tuberculosis) within 1 week prior to first administration of study drug.
12. Clinically significant cardiac disease, including myocardial infarction within 6 months before first administration of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function,uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities,a baseline corrected QT interval (QTc) >470 msec
13. Prior allogeneic bone marrow transplan
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