Primary nonsquamous non-small cell lung cancer (NSCLC) stage IIIb/IV with wild-type KRAS MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) Med
Conditions
Sponsors
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of inoperable stage IIIB or IV primary pulmonary nonsquamous NSCLC (according to UICC staging valid until 2008) - Sufficient representative sample material for KRAS analysis - Wild-type KRAS - Informed consent of the patient - Aged at least 18 years - WHO Performance Status 0-2 - At least one unidimensional, measurable tumour parameter according to RECIST - Life expectancy of al least 12 weeks - Adequate haematological, hepatic, renal and metabolic function parameters: Leukocytes > 3000/mm³, ANC = 1500/mm3, platelets = 100,000/mm3, Creatinine clearance = 50 ml/min and serum creatinine = 1.5 x upper limit of normal Bilirubin = 1.5 x upper limit of normal, GOT-GPT = 2.5 x upper limit of normal in absence of liver metastases, or = 5 x upper limit of normal in presence of liver metastases, AP = 5 x upper limit of normal Magnesium = lower limit of normal; calcium = lower limit of normal Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: - Prior chemotherapy - Clinically manifest, uncontrolled brain metastases - Prior radiotherapy of the parameters to be measured - Peripheral neuropathy NCI grade > 1 - Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. - Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). - Serious concurrent diseases - Major surgery within the last 4 weeks before recruitment - On-treatment participation in a clinical study in the period 30 days prior to inclusion - Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment. - Ongoing or active infection, including active tuberculosis or known infection with human immunodeficiency virus - Superior vena cava syndrome contraindicating hydration - History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. - Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDS) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption. - Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures - Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures - Prior or concurrent malignancy (= 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free - Known allergic reactions on study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the efficacy of the combination consisting of cisplatin/pemetrexed and panitumumab in patients with wild-type KRAS (non-mutated status) in terms of progression-free survival rate at 6 months.;Secondary Objective: - Determination of the tumour response - Duration of response - Overall survival - Adverse effects / toxicity - Quality of life assessment Additionally, genetic analyses of tumor tissue and blood samples are performed to identify predictive markers.;Primary end point(s): Progression-free survival rate after 6 months;Timepoint(s) of evaluation of this end point: At 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Determination of the tumour response 2. Duration of response 3. Overall survival 4. Adverse effects / toxicity 5. Quality of life assessment ;Timepoint(s) of evaluation of this end point: 1. At 12 weeks (end of chemotherapy treatment) 2. At end of Follow-Up (2 years) 3. At end of Follow-Up (2 years) 4. At end of Follow-Up (2 years) 5. At end of Follow-Up (2 years) | — |
Countries
Germany
Contacts
Public ContactMedical Consulting
GWT-TUD GmbH
Outcome results
None listed