Lung Cancer Clinical Trial
— ETOfficial title:
A Multicentre, Randomised, Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology, accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV disease. The recommended treatment for advanced disease is a doublet platinum-based chemotherapy, although the survival benefits are modest. Even among those fit enough for chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005; Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al, 2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this disease.
Status | Terminated |
Enrollment | 648 |
Est. completion date | |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
INCLUSION CRITERIA 1. Histological confirmation of non-squamous NSCLC 2. Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status 3. 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) 4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours 5. Either sex, at least 18 years of age 6. ECOG performance status 0-1 7. Estimated life expectancy of at least 8 weeks 8. Adequate bone marrow function as evidenced by the following (assessed within 14 days of registration): - Absolute neutrophil count (ANC) =1.5 × 109/L - Platelet count =100 × 109/L - Haemoglobin =9 g/dL 9. 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 - Alanine transaminase (ALT) =3 × ULN 10. Adequate renal function as evidenced by the following (assessed within 14 days of registration): - GFR > 60ml/min as measured by creatinine clearance through EDTA. Alternatively, the Cockcroft and Gault formula may be used to estimate GFR, but if < 60 ml/min then EDTA should be performed. 11. Previous palliative radiotherapy to non-target metastatic lesions is allowed for pain relief prior to starting chemotherapy 12. Patients with stable brain metastases will be allowed to enrol. Stable brain metastases being defined as no progression of brain metastases 28 days after treatment as documented by a CT scan/MRI of the brain. Patients with incidentally discovered asymptomatic brain metastases may be enrolled and treated with trial chemotherapy without prior brain irradiation if deemed feasible by the treating physician 13. Signed informed consent form 14. Use of effective contraception during, and for 6 months after trial treatment by patients of reproductive potential and partners of reproductive potential. Patients who receive aprepitant (anti-emetic) must be willing to use an alternative or back-up method to hormonal contraceptives as aprepitant may reduce their efficacy. Female patients with childbearing potential must have a negative serum pregnancy test prior to registration. EXCLUSION CRITERIA 1. Cytologically or clinically diagnosed NSCLC 2. 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 3. Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy 4. 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 5. Yellow fever vaccination received within the 30 days previous to study entry 6. Unable to interrupt aspirin or other NSAIDs (for pemetrexed arms of the trial) 7. Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial) 8. 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 9. Pregnant or lactating women 10. Inability to comply with protocol or trial procedures |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | Cancer Research UK, Eli Lilly and Company |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Dec 2014 | No | |
Secondary | Time to progression | Dec 2014 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|