Stage IV Non-small Cell Lung CancerPROPHETICNCT04056247
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
An observational study of Stage IV Non-small Cell Lung Cancer and Stage IV Malignant Melanoma, run by OncoHost Ltd. at 41 sites in 5 countries.
Trial summary
The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer
- What is being tested?
- Plasma sample collection
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 41 sitesin 5 countries
- Study dates
- 1 Oct 2019to 1 Oct 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment. 2. Stage III unresectable NSCLC patients treated with ICI therapy or ICI in combination with chemotherapy. 3. Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population). 4. Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy. 5. Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.
Who may be able to join
- Provision of informed consent prior to any study-specific procedures.
- Male or female aged at least 18 years.
- ECOG PS - 0/1-2
- Normal hematologic, renal and liver function:
- Absolute neutrophil count higher than 1500/mm3
- Platelets count higher than 100,000/mm3
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- haemoglobin higher than 9 g/dL
- Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
- Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.
- At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).
Who cannot join
- 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.
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
Israel14 sites
Haemek Medical Center
Afula
Barzilai Medical Center
Ashkelon
Shamir Medical Center
Be’er Ya‘aqov
Soroka Medical Center
Beersheba
Bnai Zion Medical Center
Haifa
Rambam Medical Center
Haifa
Hadassah Medcial Center
Jerusalem
Meir medical center
Kfar Saba
Rabin Medical Center
Petah Tikva
Kaplan Medical Center
Rehovot
Assuta Medical Cetner
Tel Aviv
Sheba Medical Center
Tel Aviv
Sourasky Medical Center
Tel Aviv
Sheba medical center
Tel Litwinsky
United States12 sites
Birmingham VAHCS
Birmingham, Alabama, 35233
Roswell Park
Buffalo, New York, 14263
Helen Nassif Community Cancer Center
Cedar Rapids, Iowa, 52403
West Clinic
Germantown, Tennessee, 38138
Michael E. Debakey VA Medical Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Florida Cancer Specialist and Research Institute
Orlando, Florida, 32827
Protean Biodiagnosics
Orlando, Florida, 32827
Northwest Community Healthcare
Rolling Meadows, Illinois, 60008
151-Christus Health St. Michael
Texarkana, Texas, 75503
United Kingdom12 sites
Aberdeen Royal Infirmary
Aberdeen
Royal Bournemouth General Hospital
Bournemouth
Bradford Teaching Hospitals
Bradford, BD9 6RJ
Cheltenham General Hospital
Cheltenham
Withybush Hospital
Haverfordwest, SA61 2PZ
Mount Vernon Cancer Centre
Northwood
The Shrewsbury and Telford Hospital
Shrewsbury
South Tyneside
South Shields, NE34 0PL
Lister Hospital
Stevenage
Sunderland Royal Hospital
Sunderland, SR4 7TP
Swansea Bay UHB Singleton Hospital
Swansea
Torbay Hospital
Torquay
Germany2 sites
Asklepois
Gauting, 82131
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126
About this study
Official title: PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.
Read the detailed description
The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.
In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.
- Conditions
- Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Unresectable Non-Small Cell Lung Cancer, Stage IIIb-d Malignant Melanoma
- Being tested
- Plasma sample collection
- Keywords
- Non-small Cell Lung Cancer, Small Cell Lung Cancer, Malignant Melanoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma sample collectionOther
Collect at least two plasma samples
| Study group | Role | What they receive |
|---|---|---|
| Stage IV NSCLC patients | Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment. Receives: Other: Plasma sample collection | |
| Stage III unresectable NSCLC patients | Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy Receives: Other: Plasma sample collection | |
| Stage IV malignant melanoma patients | Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population). Receives: Other: Plasma sample collection | |
| Stage IIIb-d malignant melanoma patients | Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy. Receives: Other: Plasma sample collection | |
| Stage IV SCLC patients | Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment. Receives: Other: Plasma sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)
Biological features are analyzed in biological samples taken from the patients as part of the study
Measured: Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care
Measured: Every 3 months or according to the standard of care
Progression Free Survival (PFS)
Collect Progression Free Survival (PFS) dates
Measured: At progression during treatment
Overall survival or last follow-up
Collect overall survival or last follow-up dates
Measured: Overall survival or last follow-up
Secondary outcomes (1)
Adverse Events (AE)
AE to treatment, as reported by the patient
Measured: Adverse events (AE) during treatment and until the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoHost Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alona Zer, MD, Principal investigator, Rambam Health Care CampusMichal Lotem, MD, Principal investigator, Hadassah Medical OrganizationJair Bar, MD, Principal investigator, Sheba Medical CenterMaya Gottfried, MD, Principal investigator, Meir Medical CenterAbed Agbaria, MD, Principal investigator, Bnai Zion Medical CenterIdo Wolf, MD, Principal investigator, Tel-Aviv Sourasky Medical CenterMahmud Abu-Amana, MD, Principal investigator, haemek medical centerRivka Katsenelson, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056247
- Sponsor's protocol ID
- OH-HRPP-001
- Acronym
- PROPHETIC
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2019
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27118493Shaked 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.
PubMed 17671170Shaked 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.
PubMed 16305351Christopoulos P, Harel M, McGregor K, Brody Y, Puzanov I, Bar J, Elon Y, Sela I, Yellin B, Lahav C, Raveh S, Reiner-Benaim A, Reinmuth N, Nechushtan H, Farrugia D, Bustinza-Linares E, Lou Y, Leibowitz R, Kamer I, Zer Kuch A, Moskovitz M, Levy-Barda A, Koch I, Lotem M, Katzenelson R, Agbarya A, Price G, Cheley H, Abu-Amna M, Geldart T, Gottfried M, Tepper E, Polychronis A, Wolf I, Dicker AP, Carbone DP, Gandara DR. Plasma Proteome-Based Test for First-Line Treatment Selection in Metastatic Non-Small Cell Lung Cancer. JCO Precis Oncol. 2024 Mar;8:e2300555. doi: 10.1200/PO.23.00555.
PubMed 38513170