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A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Disease Related

- Histologically or cytologically confirmed non-small cell lung cancer.

- Subjects must have advanced non-small cell lung cancer defined as stage IIIB
with malignant pleural effusion or stage IV or recurrent disease.

- Planning to receive up to 6 cycles of chemotherapy

- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic

- Men or women > 18 years of age Ethical

- Adequate Hematological, renal, hepatic and coagulation function General

- Plan to begin protocol specific therapy < 7 days after enrollment/randomization

Exclusion Criteria:

- Disease Related

- Untreated or symptomatic central nervous system metastases. Subjects with a
history of brain metastases are eligible if definitive therapy has been
administered (surgery and/or radiation therapy), there is no planned treatment
for brain metastasis and the subject is clinically stable and off
corticosteroids for at least 14 days before enrollment/randomization.

- Prior chemotherapy as follows:

- Any prior chemotherapy for advanced non-small cell lung cancer

- Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior
to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior
to randomization is permitted.

- Any prior chemoradiation.

- Central (chest) radiation therapy < 28 days prior to randomization, radiation
therapy for peripheral lesions < 14 days prior to enrollment/randomization

- Other abnormal medical conditions

- Documented myocardial infarction or unstable/uncontrolled cardiac condition

- History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or
hemorrhagic disorders

- Major surgical procedure < 30 days prior to enrollment/randomization or not yet
recovered from prior major surgery, Minor surgical procedure < 7 days prior to
enrollment/randomization or not yet recovered from prior minor surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20060295

NCT ID:

NCT00534027

Start Date:

January 2008

Completion Date:

March 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Non-Small Cell Lung Cancer
  • Paclitaxel
  • Carboplatin
  • AMG 655
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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