A randomised study comparing placebo and a not yet approved drug CS1008, in combination with drugs Carboplatin and Paclitaxel in patients with non small cell lung cancer which has spread or can not be removed by surgery, who have not had chemotherapy treatment before. The study is double-blind (that is when neither the patient nor the investigator know which treatment the patient is receiving).

• Conditions: 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: 14.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004574-11-DE
• Lead Sponsor: Daiichi Sankyo Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-07
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 < 1.5 mg/dL or creatinine clearance > 60 mL/min;
- AST, ALT, and alkaline phosphatase = 5.0 x ULN if liver or bone metastasis;
- Total bilirubin 6. Women of childbearing potential and men must be willing to consent to using highly effective methods of
contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device)
while on treatment and for at least 3 months thereafter.
7. Males with the potential to father children and women of childbearing potential must use two of the following
methods of contraception acceptable for the study (eg, hormonal contraceptives, bilateral tubal ligation, barrier
with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
8. All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result = 72
hours before initiating study treatment.
9. Subjects must be fully informed about their illness and the investigational nature of the study protocol
(including foreseeable risks and possible side effects) and must sign and date an independent ethics committee
(IEC)-approved informed consent
form (ICF) before performance of any study-specific procedures or tests.
10. Life expectancy of at least 12 weeks.
Note: symbol >/= 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified