CS-1008 With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:

Randomised, Double-Blinded, Placebo Controlled, Phase 2 Study of CS-1008 in Combination With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991796
• Other study ID #: CS1008-A-E202
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: September 7, 2012
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect on toxicity of the addition of CS 1008 to a platinum based chemotherapy regimen on the progression-free survival (PFS) in subjects with stage IIIB wet or stage IV NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Measurable disease as defined by RECIST criteria

• Adequate organ and bone marrow function as evidenced by:

• Hemoglobin >= 9 g/dL;

• ANC >= 1.5 x 109/L;

• Platelet count >= 100 x 109/L;

• Serum creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min;

• AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal (ULN) if without liver metastasis and <= 5.0 x ULN if liver metastasis;

• Total bilirubin <= 2.0 x ULN.

• Men and women of childbearing potential must be willing to consent to using effective double barrier contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicidal, intrauterine device) while on treatment and for 3 months thereafter.

• All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result <= 72 hours before initiating study treatment.

• 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 IEC approved ICF before performance of any study specific procedures or tests.

Exclusion Criteria:

• Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study.

• Prior treatment with chemotherapy for their disease.

• 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.. See Section 17.2 for NYHA Classification.

• Clinically significant pleural or pericardial effusions.

• Grade 2 or higher current peripheral neuropathy (See Section 17.3; NCI CTCAE, Version 3.0).

• 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.

• 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.

• Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.

• Previous treatment with chemotherapy, CS 1008, other agonistic DR 5 or DR 4 antibodies, or with TRAIL.

• Pregnant or breast feeding.

• Known history of hypersensitivity reactions to any of the components of CS 1008, carboplatin, or paclitaxel formulations.

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• CS-1008
CS-1008 powder for concentrate for solution for infusion. six cycles of combination therapy with 3 weeks equal to one cycle. 10 mg/kg
• Placebo
Placebo
• Paclitaxel
Paclitaxel concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 175 mg/m2
• Carboplatin
Carboplatin concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 6 mg/m2

Locations

Country	Name	City	State
Germany	Asklepios Fachkliniken Munchen Gauting	Gauting
Germany	Zentrum fur Pneumologie und Thoraxchirurgie	Grobhansdorf

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin		6 months	No
Secondary	Difference in overall survival of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin		1 year	No
Secondary	Difference in objective response rate (ORR) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin		1 year	No
Secondary	Difference in duration of response of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin		1 year	No