Patients with histologically proven and completely resected (R0) stage Ib, IIa or IIb non-small cell lung cancer (NSCLC). MedDRA version: 14.0 Level: PT Classification code 10029518 Term: Non-small cell lung cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10029517 Term: Non-small cell lung cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients with histologically proven and completely resected (R0) stage Ib, IIa or IIb NSCLC. [2] Complete NSCLC tumor resection (R0) by pneumonectomy or lobectomy (sublobar and wedge resection excluded) with resection of any involved N1 lymph nodes, within 3-6 weeks prior to study enrollment. [3] Patients must have been surgically proven to be N2 negative. [4] Performance status of 0 or 1 on the ECOG performance status scale. [5] No previous antitumor- (chemo-, hormonal-, immuno-) therapy. [6] No previous antitumor-radiation therapy. [7] Patients are compliant and live within geographic proximity that allows adequate follow-up. [8] Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L, platelets >=100 x 109/L, and hemoglobin >=9 g/dL. Hepatic: bilirubin = 45 mL/min based on the standard Cockroft and Gault formula. [9] Signed informed consent document. [10] At least 18 years of age. [11] For women: Patients are compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating. For men: Patients are compliant with a contraceptive regimen during and for 3 months after the treatment period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [12] 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. [13] Patient has previously completed or withdrawn from this study or any other study investigating pemetrexed. [14] A serious concomitant systemic disorder (e.g., active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. [15] Any concomitant systemic disorder that prohibits or interferes with the administration of one of the combination drugs (cisplatin and/or carboplatin). [16] Post-operative complications or other surgery related conditions that could interfere with a study participation. [17] Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures. [18] A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. [19] A significant cardiovascular disease in terms of an abnormal electrocardiogram (ECG) coupled with clinical signs of recent or recurrent cardiac disease (including myocardial infarction within the last 6 months, angina or uncontrolled hypertension). [20] Patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period starting 2 days before administration of pemetrexed (8-day period before long-acting agents such as piroxicam). [21] Clinically significant effusions (pleural or peritoneal) that cannot be drained. [22] Pregnancy or breast-feeding. [23] Concurrent administration of any other antitumor therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the feasibility of an adjuvant chemotherapy of pemetrexed, in combination with either cisplatin or carboplatin in patients with completely resected stage Ib or IIa/IIb NSCLC. Feasibility is defined as administration of pemetrexed randomly combined with either cisplatin or carboplatin for 4 consecutive cycles as defined per protocol. ;Secondary Objective: The secondary objectives of the study are to characterize the quantitative and qualitative potential toxicities and the necessity of dose reductions and cycle delays due to toxicities of either treatment arm. To assess time to event efficacy parameters in both treatment arms including Overall survival and 3 year disease free survival. To assess biomarkers relevant to pemetrexed and disease state and their correlation to clinical outcome (including overall survival, 3 year disease free survival and toxicity) ;Primary end point(s): Administration of pemetrexed randomly combined with either cisplatin or carboplatin for 4 consecutive cycles as defined per protocol. | — |
Countries
Germany, Spain
Outcome results
None listed