Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)
Verified date | April 2011 |
Source | Ontario Clinical Oncology Group (OCOG) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and - Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and - At least 18 years of age. Exclusion Criteria: - Previous erlotinib therapy; or - Planned concurrent chemotherapy; or - Expected survival of less than 3 months; or - ECOG Performance Status of 3 or 4; or - Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or - Granulocyte count <1,500/mm3, platelet count <100,000/mm3, or haemoglobin <9.0g/dl; or - SGOT (AST) or SGPT (ALT) > 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or > 5 x ULN in case of known liver metastases; or - Alkaline phosphatase (ALP) > 2.5 x ULN; or - Serum bilirubin > 1.5 ULN; or - Serum creatinine > 1.5 ULN or creatinine clearance < 60 ml/min; or - Serum calcium beyond ULN; or - Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or - A history of interstitial lung disease; or - Known sensitivity to erlotinib; or - Pregnancy, lactation, or parturition within the previous 30 days; or - Unwillingness or inability to complete the required assessments of the trial; or - Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or - History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye. - Geographically inaccessible for treatment or follow-up evaluations; or - Involved in an ongoing therapeutic trial. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Cancer Centre | Hamilton | Ontario |
Canada | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ontario Clinical Oncology Group (OCOG) | Roche Pharma AG |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy | 4 weeks post radiotherapy | No | |
Secondary | The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3 | 4 weeks post radiotherapy | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |