Treatment of metastatic or unresectable non small cell lung cancer (NSCLC) with CS 1008 or placebo first in combination with carboplatin/paclitaxel then as monotherapy in the first line setting MedDRA version: 14.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Product Name: CS-1008
Product Code: CS-1008
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: tigatuzumab
CAS Number: 918127-53-4
Current Sponsor code: CS-1008
Sponsors
Daiichi Sankyo Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed, stage IIIB wet or stage IV NSCLC. 2. At least 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) criteria. 5. Adequate organ and bone marrow function as evidenced by: - Hemoglobin >/= 9 g/dL; - Absolute neutrophil count >/= 1.5 x 10(e +9)/L; - Platelet count >/= 100 x 10(e +9)/L; - Serum creatinine 60 mL/min; - AST, ALT, and alkaline phosphatase /= is for greater or equal to. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
Exclusion criteria: 1. Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study for NSCLC. 2. No recurrent NSCLC or presence of clinically significant ascites. 3. Prior treatment with chemotherapy investigational medicinal products, or biological treatment for NSCLC. 4. Prior radiotherapy with curative intent for NSCLC. 5. Palliative radiotherapy for NSCLC within 4 weeks prior to first dose. 6. Major surgery within 4 weeks prior to first dose. 7. History of any of the following conditions within 6 months before study enrolment: myocardial infarction; New York Heart Association (NYHA) class II or higher severe/unstable angina pectoris; coronary/peripheral artery bypass graft; NYHA class III or IV congestive heart failure; cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma); clinically significant pulmonary edema or anasarca. 8. Clinically significant pleural or pericardial effusions. 9. Grade 2 or higher current peripheral neuropathy 10. Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. 11. History of malignancy other than NSCLC, unless there is the expectation that the malignancy has been cured, and tumor-specific treatment for the malignancy has not been administered within the previous 5 years. 12. Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV)-positive subjects receiving antiretroviral therapy. 13. Previous treatment with CS-1008, other agonistic DR 5 or DR 4 antibodies, or with TRAIL. 14. Pregnant or breast feeding. 15. Known history of hypersensitivity reactions to any of the components of CS-1008, carboplatin, or paclitaxel formulations. 16. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the difference in progression free survival (PFS) in previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC treated with CS 1008 plus carboplatin/paclitaxel versus subjects treated with placebo plus carboplatin/paclitaxel. ;Secondary Objective: To evaluate the safety and tolerability of CS 1008 plus carboplatin/paclitaxel; To evaluate the difference between the two treatment regimens CS-1008 plus carboplatin/paclitaxel and placebo (sodium Chloride) plus carboplatin/paclitaxel with respect to: - Overall survival (OS); - Objective response rate (ORR); - Duration of response; To determine the safety and tolerability of CS-1008 administered in combination with carboplatin/paclitaxel to previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC. ;Primary end point(s): The primary efficacy endpoint is the difference in PFS in previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC treated with CS-1008 plus carboplatin/paclitaxel versus subjects treated with placebo plus carboplatin/paclitaxel. Additional exploratory assessments may include protein expression and genotype/gene expression of critical genes related to NSCLC or its treatment, possibly including but not limited to DR5, Bax, Bcl-x, cIAP, GALNT-14, and Mcl-1, in available archived tumour samples.;Timepoint(s) of evaluation of this end point: PFS data would be considered mature at 10 months after the last subject is randomised, or when 85 PFS events will have occurred, whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: It is projected that OS data will become mature when all subjects will have either died or been lost to follow-up, or at 24 months after the last subject is randomised, whichever is earlier. The actual final analysis date will depend on the study information.;Secondary end point(s): As per the protocol: • To evaluate the difference between the two treatment regimens CS-1008 plus carboplatin/paclitaxel and placebo plus carboplatin/paclitaxel with respect to: • Overall survival (OS); • Objective response rate (ORR); • Duration of response; • To determine the safety and tolerability of CS-1008 administered in combination with carboplatin/paclitaxel to previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC. | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
Daiichi Sankyo Development Limited
Outcome results
None listed