Description:
This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC
(dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in
patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal
growth factor receptor).
Title
- Brief Title: Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC
- Official Title: A Randomized Phase II Study to Evaluate Efficacy and Safety of DCVAC/LuCa Added to Chemotherapy With Carboplatin and Pemetrexed vs Chemotherapy Alone in Patients With Stage IV Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
ILU02
- NCT ID:
NCT02669719
Conditions
- Non Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
chemotherapy followed dendritic cells | | chemotherapy followed dendritic cells |
pemetrexed and carboplatin | | chemotherapy |
Purpose
This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC
(dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in
patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal
growth factor receptor).
Detailed Description
Screening period: Patients will be screened for eligibility for the clinical study within a
4-week period.
Randomization and leukapheresis periods: When the patients meet all entry criteria, they will
be randomized in a ratio of 1:1 into one of the following two groups:
Group A (experimental group): Treatment with DC in addition to chemotherapy with 4-6 cycles
of pemetrexed/carboplatin as first-line induction chemotherapy followed by pemetrexed as
maintenance therapy. These patients will undergo leukapheresis within 1 week after
randomization before start of treatment.
Group B (control group): Chemotherapy with 4-6 cycles of pemetrexed/carboplatin as first-line
induction chemotherapy followed by pemetrexed as maintenance therapy.
Treatment periods:
Standard of care chemotherapy will be administered to patients in both treatment groups in
cycles. Each chemotherapy cycle will be 3 weeks long. Patients in the group A will start with
chemotherapy 2-5 days after leukapheresis, and patients in the group B will start with
chemotherapy within 2 weeks after randomization.
Induction chemotherapy period
Pemetrexed in combination with carboplatin will be administered on Day 1 of each 3-week
chemotherapy cycle. After 2 cycles of chemotherapy, tumor response will be evaluated
according to RECIST v. 1.1. Patients with progressive disease or intolerance to chemotherapy
will terminate study treatment but will be followed for survival. Patients with complete
response, partial response, or stable disease will continue chemotherapy with carboplatin and
pemetrexed for a total of 6 cycles . After at least a total of 4 cycles of chemotherapy,
patients can be administered pemetrexed maintenance chemotherapy.
Maintenance chemotherapy period
During the Maintenance chemotherapy period, patients will receive pemetrexed of each 3-week
chemotherapy cycle. Chemotherapy with pemetrexed will be administered in up to a total of 21
cycles or until disease progression or development of intolerance.
DCVAC
Patients in the group A will start with DC treatment on Day 15 of chemotherapy Cycle 3
provided.During the Induction chemotherapy period, DC will be administered on Day 15 of each
subsequent 3-week chemotherapy cycle of chemotherapy. During the Maintenance chemotherapy
period, DC will be administered on Day 15 of every other 3-week chemotherapy cycle.
Follow-up periods: Patients who complete or discontinue all study treatments after Cycle 3
before disease progression will undergo disease evaluation by CT scan every 3 months until
progression of the disease.Patients who discontinue all study treatments before or at Cycle 2
for any reason or those who complete or discontinue all study treatments after Cycle 3 after
disease progression will be followed up for survival. The survival data will be collected
every 3 months by directly contacting the patient (or a relative/caretaker) by phone until
death from any reason or termination of the study. The clinical study will be terminated when
at least 45 PFS (progression-free survival) events have been reached, which is assumed to
happen approximately 24 months after start of treatment of the first patient included in the
study.
Trial Arms
Name | Type | Description | Interventions |
---|
chemotherapy followed dendritic cells | Experimental | pemetrexed and carboplatin chemotherapy followed dendritic cells infusion from Cycle 3 | - chemotherapy followed dendritic cells
|
chemotherapy | Active Comparator | pemetrexed and carboplatin chemotherapy only | - pemetrexed and carboplatin
|
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically confirmed stage IV, non-squamous, wild-type
EGFR,ALK-negative NSCLC
2. Signed ICF and ability to comply with this protocol
3. 18 years of age or older
4. ECOG performance status of 0-1
5. Patients must have measurable disease as defined by RECIST v. 1.1
6. Systematic treatment naive with respect to the currently diagnosed NSCLC
7. Patients must have recovered from toxicity of previous therapy. Recovery is defined as
less than or equal to grade 2 toxicity according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE) (except alopecia).
8. Sufficient hematologic and organ function for leukapheresis and chemotherapy:
- WBC equal to or higher than 4×10^9 /L
- Neutrophil equal to or higher than 1.5×10^9 /L
- PLT equal to or higher than 100×10^9 /L
- Hemoglobin equal to or higher than9 g/dL (90 g/L)
- Total bilirubin less than or equal to 1.5 times upper limit of normal (benign
hereditary hyperbilirubinemias, eg, Gilbert's syndrome are permitted)
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
alkaline phosphatase (ALP) should be less than or equal to 3 times upper limit of
normal. ALP, AST, and ALT less than or equal to 5 times upper limit of normal is
acceptable if liver has tumor involvement.
- Creatinine clearance equal to or higher than 45 mL/min (calculated with the
standard Cockcroft and Gault formula)
9. Women of childbearing potential and sexually active males must agree to use an
accepted and effective method of contraception (hormonal or barrier methods,
abstinence) prior to study entry and for the duration of the treatment plus 3 months
Exclusion Criteria:
1. Known active/untreated CNS metastases
2. Any known primary immunodeficiency
3. Any preexisting medical condition requiring long term chronic steroid or
immunosuppressive therapy
4. HIV positivity, hepatitis B and/or C infection, syphilis
5. Past or current history of malignant neoplasm other than lung carcinoma, except for
adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other
cancer curatively treated and with no evidence of disease for at least five years
6. Patient's significant co-morbidities:
- Cardiovascular diseases - unstable angina pectoris, uncontrolled hypertension,
myocardial infarction or ventricular arrhythmia or stroke within a 6-month period
before randomization, congestive heart failure or cardiac arrhythmia not
controlled by treatment
- Active severe infections or other severe medical condition
7. Participation in a clinical study using experimental therapy and
immunotherapy,monoclonal antibodies within the last 4 weeks prior to study entry
8. Pregnant or breastfeeding woman
9. History of severe hypersensitivity to pemetrexed and carboplatin and their
ingredients, and to DCVAC ingredients
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | the time from the date of randomization to the date of an event defined as the first progression or death due to any cause, whichever occurs first, up to 24 months |
Safety Issue: | |
Description: | randomization to the date of an event defined as the first progression or death due to any cause (institution of a new systemic anticancer treatment will also be considered as a progression event),whichever occurs first up to 24 months |
Secondary Outcome Measures
Measure: | Safety parameters in terms of AE, laboratory abnormalities, and vital signs |
Time Frame: | through study completion, an average of 24 months |
Safety Issue: | |
Description: | adverse events [AEs], serious adverse events [SAEs], adverse events of special interest [AESIs], laboratory abnormalities, and vital signs |
Measure: | Overall Survival |
Time Frame: | From study treatment to death due to any cause, up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate |
Time Frame: | Objective Response Rate measured by RECIST criteria in ITT population, up to 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Shanghai Chest Hospital |
Trial Keywords
- Lung Cancer
- Chemotherapy
- Immunotherapy
Last Updated
February 1, 2016