Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC

NCT02669719 | Unknown Phase 2

• 1 other identifier: ILU02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer; Chemotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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

  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

Secondary Outcomes (3)

• Safety parameters in terms of AE, laboratory abnormalities, and vital signs

  through study completion, an average of 24 months

• Overall Survival

  From study treatment to death due to any cause, up to 24 months

• Objective Response Rate

  Objective Response Rate measured by RECIST criteria in ITT population, up to 24 months

Study Arms (2)

chemotherapy followed dendritic cells

EXPERIMENTAL

pemetrexed and carboplatin chemotherapy followed dendritic cells infusion from Cycle 3

Biological: chemotherapy followed dendritic cells

chemotherapy

ACTIVE COMPARATOR

pemetrexed and carboplatin chemotherapy only

Drug: pemetrexed and carboplatin

Interventions

chemotherapy followed dendritic cells BIOLOGICAL

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.

chemotherapy followed dendritic cells

pemetrexed and carboplatin DRUG

Chemotherapy with 4-6 cycles of pemetrexed and carboplatin as first-line induction chemotherapy followed by pemetrexed as maintenance therapy.

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed stage IV, non-squamous, wild-type EGFR,ALK-negative NSCLC
• Signed ICF and ability to comply with this protocol
• 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:
• 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)

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• SOTIO a.s.: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Baohui Han, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baohui Han, MD

CONTACT

86-21-62821990; xkyyhan@gmail.com

Hua Zhong, MD

CONTACT

86-21-62821990; eddiedong8@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2019
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

CN (1)