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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).
Full 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.
Enrollment
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Inclusion criteria
Histologically or cytologically confirmed stage IV, non-squamous, wild-type EGFR,ALK-negative NSCLC
Signed ICF and ability to comply with this protocol
18 years of age or older
ECOG performance status of 0-1
Patients must have measurable disease as defined by RECIST v. 1.1
Systematic treatment naive with respect to the currently diagnosed NSCLC
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).
Sufficient hematologic and organ function for leukapheresis and chemotherapy:
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
Known active/untreated CNS metastases
Any known primary immunodeficiency
Any preexisting medical condition requiring long term chronic steroid or immunosuppressive therapy
HIV positivity, hepatitis B and/or C infection, syphilis
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
Patient's significant co-morbidities:
Participation in a clinical study using experimental therapy and immunotherapy,monoclonal antibodies within the last 4 weeks prior to study entry
Pregnant or breastfeeding woman
History of severe hypersensitivity to pemetrexed and carboplatin and their ingredients, and to DCVAC ingredients
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups
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Central trial contact
Baohui Han, MD; Hua Zhong, MD
Data sourced from clinicaltrials.gov
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