NCT02669719

Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	chemotherapy followed dendritic cells	Pemetrexed and carboplatin would be administered on day 1 of each 3-week cycle.Patients will start with dendritic cells treatment on Day 15 of pemetrexed and carboplatin chemotherapy from Cycle 3 provided that both leukapheresis and the production of dendritic cells are successful.
DRUG	pemetrexed and carboplatin	Chemotherapy with 4-6 cycles of pemetrexed and carboplatin as first-line induction chemotherapy followed by pemetrexed as maintenance therapy.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2019-01-01
• First posted: 2016-02-01
• Last updated: 2016-02-01

Locations

1 site across 1 country: China