Phase 2
N=30
Molecular Profiling in Lung Cancer Patients
Non-Small Cell Lung Cancer · Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00191308 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Apr 2010
Primary outcome: Primary: High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug); cisplatin (Drug); Radical Non-Small Cell Lung Cancer (NSCLC) surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood |
— | — |
| SECONDARY Percentage of Participants With Objective Tumor Response (Response Rate) |
34.5 | — |
| SECONDARY Duration of Response |
42.5 | — |
| SECONDARY Disease Free Survival (DFS) |
43.7 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
Summary
The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00191308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.