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A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Squamous Non-Small-Cell Lung Cancer

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Trial Information

A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumour response rate at 18 weeks.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493

Authority:

Hungary: National Institute of Pharmacy

Study ID:

C79102

NCT ID:

NCT00152477

Start Date:

August 2005

Completion Date:

June 2009

Related Keywords:

  • Carcinoma
  • Non-Squamous Non-Small-Cell Lung Cancer
  • Non-small-cell-lung cancer
  • carboplatin
  • paclitaxel
  • VEGF
  • monoclonal antibody
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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