A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 (10 or 20 mg/kg) Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic (Stage IIIb With Pleural Effusion or Stage IV) Non-Squamous Non-Small-Cell Lung Cancer

• Conditions: on squamous non small cell lung cancer

• Registration Number: EUCTR2005-001731-30-HU
• Lead Sponsor: CB Celltech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

1. Male and female subjects with histologically or cytologically confirmed Stage IIIb (with malignant pleural effusion), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the subject is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
2.The subject must be aged 18 years or above.
3.The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
4.Subjects will have measurable disease defined as at least one lesion that is measurable in one dimension (RECIST evaluation (Therasse P, et al; 2000)).
5.The subject must be able to understand the information provided to them and to give written informed consent.
6.Female subjects must be either postmenopausal (last menstrual period more than two years prior to study), surgically sterilized, or using a method of contraception judged reliable by the Investigator.
7.Male subjects must be using a method of contraception judged reliable by the Investigator.
8.Subjects must have adequate renal function as determined by the following tests within one week prior to randomization:Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN), AND urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace).If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate < 500 mg of protein in 24 hours to allow participation in the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with squamous cell lung carcinoma.
2.Subjects with lung lesions located centrally in the chest that involve major blood vessels.
3.Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
4.Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
5.Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
6.Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
7.Subjects should not have abnormal organ function indicated by: ·
Bilirubin greater than the ULN·
AST or ALT greater than 2.5 times ULN (no liver metastases)·
AST or ALT greater than 5 times ULN (liver metastases present)·
Creatinine greater than 1.5 times ULN·
Proteinuria greater than Grade 1 NCI CTC·
Hemoglobin less than 9g/dL (subjects may be transfused to meet this requirement)
White cell count less than 3 x 10(9)/L ·
Absolute neutrophil count less than 1500/mm³
Platelet count less than 100 x 10(9)/L·
Abnormal activated partial thromboplastin time (APTT)·
Abnormal prothrombin time (PT)

8.Subjects who have or who are suspected to have brain metastases. A head CT or MR is required within four weeks of study entry.
9.Major surgery within four weeks or open biopsy within one week of planned study drug administration.
10.Non healing wound or ulcer.
11.Previous chemotherapy or immunotherapy (registered, off label or experimental).
12.Radiotherapy within two weeks of first dose of study drug.
13.History of clinically significant adverse reaction to biological products or polyethylene glycol.
14.Known alcohol or drug dependency.
15.Subjects must not weigh more than 150 kg.
16.Subjects must not be pregnant or breast feeding.

Study & Design

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