Non-small cell lung cancer MedDRA version: 14.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Alimta
Product Name: Pemetrexed
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PEMETREXED
CAS Number: 137281-23-3
Concentration unit: mg milligram(s)
Conce
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Histologically confirmed NSCLC b) Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status c) Presentation with stage IIIb (not amenable to curative treatment) or IV disease staging scans must be no more than 28 days prior to registration. Patients with relapsed NSCLC must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed) d) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) e) Either sex, at least 18 years of age f) ECOG performance status 0-1 g) Estimated life expectancy of at least 8 weeks h) Adequate bone marrow function as evidenced by the following (assessed within 14 days of starting treatmentregistration): - Absolute neutrophil count (ANC) =1.5 × 10^9/L - Platelet count =100 × 10^9/L - Haemoglobin =9 g/dL i) Adequate liver function as evidenced by the following (assessed within 14 days of registration): - Total bilirubin = 1.5 x upper limit of normal (ULN) - Aspartate transaminase (AST) =3 × ULN or =5 × ULN is acceptable with liver metastases, OR - Alanine transaminase (ALT) =3 × ULN or =5 × ULN is acceptable with liver metastases j) Adequate renal function as evidenced by the following (assessed within 14 days of registration): - GFR > 60ml/min as measured by EDTA. The Cockcroft and Gault formula (see appendix 5) may be used to estimate GFR, but if =65 years) yes F.1.3.1 Number of subjects for this age range 1272
Exclusion criteria
Exclusion criteria: a) Cytologically or clinically diagnosed NSCLC b) Evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial, e.g congestive heart failure; myocardial infarction within 6 months; significant neurological or psychiatric disorders that would impact trial participation; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at trial entry; superior vena cava syndrome, except if controlled with radiation; active peptic ulcer disease; uncontrolled diabetes mellitus ; any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease c) Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy d) Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry e) Yellow fever vaccination received within the 30 days previous to study entry f) Unable to interrupt aspirin or other NSAIDS (for pemetrexed arms of the trial) g) Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial) h) A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer i) Pregnant or lactating women j) Inability to comply with protocol or trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial will have two main objectives: 1) To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment. 2) To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment. ;Secondary Objective: · To examine progression-free survival, response rate and quality of life between the two treatment regimens, according to ERCC1 status. · To investigate whether the treatment effect differs according to histology (squamous vs non-squamous); gender (males vs females); performance status · To undertake a cost-effectiveness analysis based on all patients, and according to ERCC1 status. ;Primary end point(s): To detect an improvement in survival for ERCC1+ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment. To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment.;Timepoint(s) of evaluation of this end point: End of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To examine progression-free survival, response rate and quality of life between the two treatment regimens, according to ERCC1 status. To investigate whether the treatment effect differs according to histology (squamous vs. non-squamous); gender (males vs. females); performance status. To undertake a cost-effectiveness analysis based on all patients, and according to ERCC1 status.;Timepoint(s) of evaluation of this end point: End of trial. | — |
Countries
United Kingdom
Contacts
Public ContactCR UK and UCL Cancer Trials Centre
University College London
Outcome results
None listed