Molecular Profiling in Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT00191308 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : April 20, 2010
Last Update Posted : October 21, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer Carcinoma | Drug: pemetrexed Drug: cisplatin Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed + Cisplatin
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs |
Drug: pemetrexed
500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Other Names:
Drug: cisplatin 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed. |
- High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood [ Time Frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed) ]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.
- Percentage of Participants With Objective Tumor Response (Response Rate) [ Time Frame: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed) ]Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.
- Duration of Response [ Time Frame: Time of response to disease progression (up to 44.4 months) ]The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.
- Disease Free Survival (DFS) [ Time Frame: Treatment start to disease progression or death from any cause (up to 45.5 months) ]DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.
- Overall Survival (OS) [ Time Frame: Treatment start to death from any cause (up to 47.6 months) ]OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 tumors)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191308
Poland | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Bystra Slaska, Poland, 43-360 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Poznan, Poland, 60-569 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Warsaw, Poland, 02-781 |
Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00191308 |
Other Study ID Numbers: |
9356 H3E-PL-S051 ( Other Identifier: Eli Lilly and Company ) |
First Posted: | September 19, 2005 Key Record Dates |
Results First Posted: | April 20, 2010 |
Last Update Posted: | October 21, 2011 |
Last Verified: | October 2011 |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |