An exploratory Phase 2 study of Pemetrexed and Cisplatin as Preoperative chemotherapy in the treatment of Stage IIIAN2 nonsquamous non-Small cell lung cancer - ND

• Register: EUCTR
• Last refreshed on: 20 June 2016
• Main ID: EUCTR2009-018148-45-IT
• Date of registration: 09/11/2010
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company Limited
• Public title: An exploratory Phase 2 study of Pemetrexed and Cisplatin as Preoperative chemotherapy in the treatment of Stage IIIAN2 nonsquamous non-Small cell lung cancer - ND
• Scientific title: An exploratory Phase 2 study of Pemetrexed and Cisplatin as Preoperative chemotherapy in the treatment of Stage IIIAN2 nonsquamous non-Small cell lung cancer - ND
• Date of first enrolment: 20/10/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018148-45
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
[1] Histologic diagnosis of NSCLC defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted). [2] Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2) (except pancoast tumors and bronchoalveolar carcinoma) as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer. [3] Tumor considered potentially resectable with no evidence of extrathoracic metastatic disease. [4] ECOG PS of 0 or 1. [5] No prior surgery, radiotherapy, systemic chemotherapy, immunotherapy, targeted, or biological therapy for NSCLC. [6] At least 1 unidimensionally measurable lesion meeting RECIST criteria version 1.1 (at least 10 mm in longest diameter [LD] by CT scan [slice thickness 5mm], or at least 20 mm LD by chest X-ray). For malignant lymph nodes, at least 15 mm in short axis when assessed by CT scan (slice thickness 5 mm). PET scans and ultrasounds may not be used for tumor measurements. [7] Estimated life expectancy of at least 6 months [8] Patient compliance and geographic proximity that allow adequate follow-up. [9] Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) > or =1.5 x 109/L, platelets > or =100 x 109/L, and hemoglobin > or = 9 g/dL. Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < or = 3.0 x ULN. Renal: calculated creatinine clearance (CrCl) > or = 45 mL/min based on the original weight-based Cockroft and Gault formula and serum creatinine < or = 1.5 x ULN. [10] Patients must sign an informed consent document (ICD). [11] Patients must be at least 18 years of age. [12] For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative serum or urine pregnancy test within 7 days before study enrollment; and must not be breast-feeding. For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug. [13] Patients must have an adequate tumor tissue sample available for detection of biomarkers expression. [14] Predicted postresection forced expiratory volume in 1 second (FEV1) > or =1.2 L. [15] Patients must be fit for surgery at time on enrollment.
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:
[16] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [17] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [18] Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [19] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. [20] Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score < or =6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [21] Are receiving concurrent administration of any other antitumor therapy. [22] Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [23] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose < or = 1.3 grams per day. [24] Are unable or unwilling to take folic acid, vitamin B12 supplementation, or corticosteroids. [25] Have had significant (>5%) weight loss within 6 months of enrollment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non Squamous Non Small Cell Lung Cancer
MedDRA version: 9.1 Level: LLT Classification code 10029520
MedDRA version: 9.1 Level: LLT Classification code 10029520

Intervention(s)

Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Primary end point(s): Overall Response rate defined as the proportion of patients whose response is Complete Response or Partial Response

Secondary Objective: - Assess pathological complete remission rate after surgery, median progression-free survival (PFS), and median overall survival (OS) - Assess tumor downstaging - Characterize quantitative and qualitative toxicities - Assess the expression of biomarkers of interest and their correlation with Overall Response Rate - Assess the expression of biomarkers and their correlation with PFS and OS - Compare baseline expression of biomarkers with the expression of the same biomarkers after 3 cycles of pemetrexed/cisplatin chemotherapy

Main Objective: Assess the antitumor activity of pemetrexed in combination with cisplatin, as measured by Overall Response Rate after preoperative chemotherapy, in patients with stage IIIAN2 nonsquamous NSCLC

Secondary ID(s)

H3E-EW-JMIP