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Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer


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

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Trial Information

Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer


Inclusion Criteria:



- Diagnosis of non-small-cell carcinoma of the lung

- Patients with locally advanced disease or metastatic disease, candidates to surgery
after evaluation by oncologist and thoracic surgeon

- Tumour with possibility of curative surgery

- At least one uni-dimensionally measurable lesion

- Adequate pulmonary function to perform the planned surgical resection

Exclusion Criteria:

- Active infection (at the investigator's discretion)

- Pregnancy or breast-feeding

- Serious concomitant illness at the investigator's discretion

- Previous diagnosis of malignant disease

- They have received treatment during the last 30 days with a drug, other than the
study drug, that has not received regulatory approval for any indication at the time
of their entry in the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment Response

Outcome Time Frame:

every 21 day cycle (3 cycles) and 3-4 weeks after last cycle

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Spain: Ministry of Health

Study ID:

9901

NCT ID:

NCT00259285

Start Date:

November 2005

Completion Date:

December 2007

Related Keywords:

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

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