Stage IV Non-small Cell Lung Cancer Clinical Trial
— PROPHETICOfficial title:
PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | October 1, 2029 |
Est. primary completion date | October 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Cancer patients with stage IV NSCLC or stage IV malignant melanoma - Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response - ECOG PS - 0/1-2 - Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration =1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels = 3 times above the upper normal limit. Exclusion Criteria: - Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug - Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study. |
Country | Name | City | State |
---|---|---|---|
Germany | Asklepois | Gauting | |
Germany | Thoraxklinik Heidelberg gGmbH | Heidelberg | |
Israel | Haemek Medical Center | Afula | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Soroka Medical Center | Be'er Sheva | |
Israel | Shamir Medical Center | Be'er Ya'aqov | |
Israel | Bnai Zion Medical Center | Haifa | |
Israel | Rambam Medical Center | Haifa | |
Israel | Hadassah Medcial Center | Jerusalem | |
Israel | Meir medical center | Kfar Saba | |
Israel | Rabin Medical Center | Petah tikva | |
Israel | Kaplan Medical Center | Re?ovot | |
Israel | Assuta Medical Cetner | Tel Aviv | |
Israel | Sheba Medical Center | Tel Aviv | |
Israel | Sourasky Medical Center | Tel Aviv | |
Israel | Sheba medical center | Tel HaShomer | |
Spain | 044 Hospital Universitario Virgen Macarena | Seville | |
United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
United Kingdom | Royal Bournemouth General Hospital | Bournemouth | |
United Kingdom | Bradford Teaching Hospitals | Bradford | |
United Kingdom | Cheltenham General Hospital | Cheltenham | |
United Kingdom | Withybush Hospital | Haverfordwest | |
United Kingdom | Mount Vernon Cancer Centre | Northwood | |
United Kingdom | The Shrewsbury and Telford Hospital | Shrewsbury | |
United Kingdom | South Tyneside | South Shields | |
United Kingdom | Lister Hospital | Stevenage | |
United Kingdom | Sunderland Royal Hospital | Sunderland | |
United Kingdom | Swansea Bay UHB Singleton Hospital | Swansea | |
United Kingdom | Torbay Hospital | Torquay | |
United States | Birmingham VAHCS | Birmingham | Alabama |
United States | Roswell Park | Buffalo | New York |
United States | Helen Nassif Community Cancer Center | Cedar Rapids | Iowa |
United States | West Clinic | Germantown | Tennessee |
United States | Michael E. Debakey VA Medical Center | Houston | Texas |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Miami | Miami | Florida |
United States | Rutgers Cancer Institute | New Brunswick | New Jersey |
United States | Florida Cancer Specialist and Research Institute | Orlando | Florida |
United States | Protean Biodiagnosics | Orlando | Florida |
United States | Northwest Community Healthcare | Rolling Meadows | Illinois |
United States | 151-Christus Health St. Michael | Texarkana | Texas |
Lead Sponsor | Collaborator |
---|---|
OncoHost Ltd. |
United States, Germany, Israel, Spain, United Kingdom,
Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020. — View Citation
Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905. — View Citation
Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events (AE) | AE, as reported by the patients | At second blood collection, 3 months and 6 months after treatment and EOS (2 years) | |
Other | Progression Free Survival (PFS) | Collect Progression Free Survival (PFS) dates | At End of study (2 years) | |
Other | Overall Survival (OS) | Collect Overall Survival (OS) dates | At End of study (2 years) | |
Other | Duration of Response (DOR) | Collect Duration of Response (DOR) dates | At End of study (2 years) | |
Primary | Overall response rate (ORR) at 3 months | ORR as defined by RECIST 1.1 or other validated method for ORR evaluation | At 3 months after therapy | |
Primary | Overall response rate (ORR) at 6 months | ORR as defined by RECIST 1.1 or other validated method for ORR evaluation | At 6 months after therapy | |
Primary | Changes in the blood levels of different proteins that represent the host response | Changes in Blood levels of proteins representing the Host response | At baseline (pre-therapy) and after 1st dose administration (post therapy) |
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