ivolumab after cyclophosphamide and doxorubicin(CA) induction therapy in previously treated advanced non-squamous cell lung cancer with PD-L1<10%
- Conditions
- Neoplasms
- Registration Number
- KCT0003455
- Lead Sponsor
- CC Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
Histologic or cytologic diagnosis of nonsquamous NSCLC
with SP263 PD-L1 expression <10% - Patients whose tumor is not known to
have anaplastic lymphma kinase(ALK) or epidermal growth factor receptor(EGFR)
mutation and Previously treated with at least one platinum-based chemotherapy
but less than 3 prior chemotherapy - Before study entry, a minimum of 21 days
must have elapsed since any prior chemotherapy. - Prior radiation therapy is
allowed as long as the irradiated area is not the only source of measurable
disease. - No other forms of cancer therapy, such as immunotherapy for at least
2 weeks before the enrollment in study. - Performance status of 0-1 on the ECOG
criteria. - At least one unidimensionally measurable lesion meeting Response
Evaluation Criteria in Solid Tumors (Revised RECIST guideline version 1.1)
- Estimated life expectancy of at least 8 weeks. - Patient compliance that allow
adequate follow-up. Adequate hematologic (WBC =4,000/mm3 ?? 4.0 x 103/? Platelet
count =130,000mm3 ?? 130 x 103/? Bilirubin total =1.0 mg/dL AST/ALT= 80 IU/L
creatinine concentration 1XULN or creatinine clearance (CrCl) > 50 mL/min
(measured using the Cockcroft-Gault formula) - Informed consent from patient or
patient’s relative. - Males or females at least 18 years of
age.
- Previous therapy with anti-PD-1 or –PD-L1 inhibitors
- Persistence of clinically relevant therapy related toxicities from previous
chemotherapy and/or radiotherapy - Has received prior chemotherapy or tyrosine
kinase inhibitor therapy within 3 weeks of the first dose of trial treatment ;
completed palliative radiotherapy(except for brain and extremities) within
2weeks of the first dose of trial treatment. Prior curative thoracic radiation
therapy(>=60Gy) is permitted if disease progression occured >4weeks after
the completion of therapy. - Treatment with other investigational drugs or
treatment in another clinical trial within the past three weeks before start of
therapy or concomitantly with this trial - Has received a live
vaccine(Concomitant yellow fever vaccin) within 4 weeks prior to the first
administration of study medication. Concomitant yellow fever vaccination
- Active 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 randomization - Leptomeningeal disease - Significant cardiovascular
diseases (i.e., hypertension not controlled by medical therapy, unstable angina,
history of myocardial infarction within the past 12 months, congestive heart
failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
- Proteinuria CTCAE grade 2 or greater - Significant weight loss (> 10 %)
within the past 6 weeks prior to treatment in the present trial - Current
peripheral neuropathy = CTCAE(version4.0) Grade 2 except due to trauma - Major
injuries and/or surgery with incomplete wound healing within the past ten days
prior to enrollment - Serious infections requiring systemic antibiotic (e.g.
antiviral, antimicrobial, antifungal) therapy - Active hepatitis C and/or B
infection - Known human immunodeficiency virus (HIV) seropositivity - Serious
illness or concomitant non-oncological disease such as neurologic-,psychiatric-,
infectious disease or active ulcers (gastro-intestinal tract, skin) or
laboratory abnormality that may increase the risk associated with study
participation or study drug administration and in the judgment of the
investigator would make the patient inappropriate for entry into the study
- Patients who are sexually active and unwilling to use a medically acceptable
method of contraception (e.g. such as implants, injectables, combined oral
contraceptives, some intrauterine devices or vasectomized partner for
participating females, condoms for participating males) during the trial and for
at least 7 months after end of active therapy - Pregnancy or breast feeding
- Psychological, familial, sociological or geographical factors potentially
hampering compliance with the study protocol and follow-up schedule - Patients
unable to comply with the protocol - Active alcohol or drug abuse - Other
malignancy within the past three years other than basal cell skin cancer or
carcinoma in situ of the cervix
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response rate using RECIST v1.1
- Secondary Outcome Measures
Name Time Method Overall Survival