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Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer, Carcinoma

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Trial Information

Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Inclusion Criteria:

- pathologic documentation of non-small cell lung cancer (NSCLC)

- tumor must be accessible by bronchoscopy for tumor tissue sample collection

- patients must have lung cancer with clinical stage IB, II, IIIA

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- patients must not have received prior systemic chemotherapy or radiation therapy for
NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed
between prior surgery and enrolment)

Exclusion Criteria:

- bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast

- pregnant or breast feeding patients

- patients who have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study entry

- patients with history or presence of other malignancy except in situ carcinoma of the
skin or prior malignancy treated more than 5 years before without recurrence
(excluding melanoma, breast cancer and hypernephroma)

- unwillingness to take folic acid or vitamin B12 supplementation

Type of Study:


Study Design:

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

Outcome Measure:

High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood

Outcome Description:

Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.

Outcome Time Frame:

Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)

Safety Issue:


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


Poland: Ministry of Health

Study ID:




Start Date:

May 2005

Completion Date:

December 2010

Related Keywords:

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