Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Chest Hospital
• Collaborator: SOTIO a.s.
• Treatments: Carboplatin; Pemetrexed

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