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A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC


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

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Trial Information

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC


Inclusion Criteria:



- Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV

- No previous systemic chemotherapy for this cancer

- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria
In Solid Tumors (RECIST) criteria

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate
organ function

- Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Exclusion Criteria:

- Serious concomitant systemic disorder or active infection

- Mild to moderate renal insufficiency, but unable to interrupt salicylates or other
nonsteroidal anti-inflammatory drugs

- Symptomatic central nervous system (CNS) metastases requiring concurrent
corticosteroid therapy

- Presence of clinically significant third-space fluid collections

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:

Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)

Outcome Time Frame:

Randomization to Month 6

Safety Issue:

No

Principal Investigator

Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

11077

NCT ID:

NCT00402051

Start Date:

November 2006

Completion Date:

May 2009

Related Keywords:

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

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