A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

UCB Pharma165 enrolled

Overview

A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.

This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer. In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791. If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy. Participants will be followed up longterm, so that survival can be measured.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Carcinoma Non-Squamous Non-Small-Cell Lung Cancer

Interventions

CarboplatinDRUG

10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.

PaclitaxelDRUG

6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.

CDP791 10mg/kgDRUG

CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria: * Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma. * The subject must be aged 18 years or above. * The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months. * Subjects will have measurable disease. * The subject must be able to understand the information provided to them and to give written informed consent. * Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator. * Male subjects must be using a method of contraception judged reliable by the Investigator. Exclusion Criteria: * Subjects with squamous cell lung carcinoma. * Subjects with lung lesions located centrally in the chest that involve major blood vessels. * 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. * 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. * Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2. * Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent). Exclusion Criteria:

Locations (21)

Unnamed facility

Budapest, Hungary

Unnamed facility

Deszk, Hungary

Unnamed facility

Mátraháza, Hungary

Outcomes

Primary Outcomes

Tumor Response Rate (RR)

Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = \>=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS): (CR + PR) / RS.

Time frame: 24 weeks

Secondary Outcomes

Progression Free Survival (PFS)

Progression free survival (PFS) is defined as time from date of randomization until the date progressive disease (PD) is first recorded or until death, whichever is first.

Time frame: Up to 57 weeks

Time to Treatment Failure

Time to treatment failure (TTF) is defined as the time from date of randomization until the date of progression, death or, for subjects who discontinued treatment for toxicity reason, their last dosing date, whichever occurs first.

Time frame: Up to 57 weeks

Overall Survival

Overall survival is defined as the time from date of randomization until the date of death.

Time frame: Up to 57 weeks

Duration of Overall Response

The duration of overall response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR), whichever is recorded first, until the first date of documented progressive disease or death.

Time frame: Up to 57 weeks

Time to Response

Time to response is defined as the time from the first dose of study therapy until measurement criteria are first met for complete response or partial response (whichever is recorded first).

Data from ClinicalTrials.gov

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