Molecular Profiling in Lung Cancer Patients

Lilly

Status and phase: Completed; Phase 2

Conditions: Carcinoma; Non-Small Cell Lung Cancer

Treatments: Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery; Drug: cisplatin; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191308

H3E-PL-S051 (Other Identifier)

9356

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Pemetrexed + Cisplatin

Experimental group

Description:

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

Treatment:

Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery

Drug: pemetrexed

Drug: cisplatin