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Active, not recruitingNCT04056247PROPHETICUpdated Oct 15, 2025

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

An observational study in Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma and Stage IV Small Cell Lung Cancer, sponsored by OncoHost Ltd.. Active, not recruiting at 41 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-15.

Sponsored by OncoHost Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • 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

Keywords

  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Malignant Melanoma
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

OncoHost Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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:

    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.
  • At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    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

    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).

    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.

    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.

    Other: Plasma sample collection

Interventions

  • OtherPlasma sample collection

    Collect at least two plasma samples

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)

  2. 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

    Time frame: Every 3 months or according to the standard of care

  3. Progression Free Survival (PFS)

    Collect Progression Free Survival (PFS) dates

    Time frame: At progression during treatment

  4. Overall survival or last follow-up

    Collect overall survival or last follow-up dates

    Time frame: Overall survival or last follow-up

Secondary outcomes

  1. Adverse Events (AE)

    AE to treatment, as reported by the patient

    Time frame: Adverse events (AE) during treatment and until the end of study

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Study locations

41 sites
  • Birmingham VAHCS
    Birmingham, Alabama 35233, United States
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Florida Cancer Specialist and Research Institute
    Orlando, Florida 32827, United States
  • Protean Biodiagnosics
    Orlando, Florida 32827, United States
  • Northwest Community Healthcare
    Rolling Meadows, Illinois 60008, United States
  • Helen Nassif Community Cancer Center
    Cedar Rapids, Iowa 52403, United States
  • Rutgers Cancer Institute
    New Brunswick, New Jersey 08903, United States
  • Roswell Park
    Buffalo, New York 14263, United States
  • West Clinic
    Germantown, Tennessee 38138, United States
  • Michael E. Debakey VA Medical Center
    Houston, Texas 77030, United States
  • 151-Christus Health St. Michael
    Texarkana, Texas 75503, United States
  • Asklepois
    Gauting, 82131, Germany
  • Thoraxklinik Heidelberg gGmbH
    Heidelberg, 69126, Germany
  • Haemek Medical Center
    Afula, Israel
  • Barzilai Medical Center
    Ashkelon, Israel
  • Soroka Medical Center
    Beersheba, 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
    Rehovot, Israel
  • Assuta Medical Cetner
    Tel Aviv, Israel
  • Sheba Medical Center
    Tel Aviv, Israel
  • Sourasky Medical Center
    Tel Aviv, Israel
  • Sheba medical center
    Tel Litwinsky, Israel
  • 044 Hospital Universitario Virgen Macarena
    Seville, Spain
  • Aberdeen Royal Infirmary
    Aberdeen, United Kingdom
  • Royal Bournemouth General Hospital
    Bournemouth, United Kingdom
  • Bradford Teaching Hospitals
    Bradford, BD9 6RJ, United Kingdom
  • Cheltenham General Hospital
    Cheltenham, United Kingdom
  • Withybush Hospital
    Haverfordwest, SA61 2PZ, United Kingdom
  • Mount Vernon Cancer Centre
    Northwood, United Kingdom
  • The Shrewsbury and Telford Hospital
    Shrewsbury, United Kingdom
  • South Tyneside
    South Shields, NE34 0PL, United Kingdom
  • Lister Hospital
    Stevenage, United Kingdom
  • Sunderland Royal Hospital
    Sunderland, SR4 7TP, United Kingdom
  • Swansea Bay UHB Singleton Hospital
    Swansea, United Kingdom
  • Torbay Hospital
    Torquay, United Kingdom
08

References and documents

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 27118493 ↗
  • 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. PubMed 17671170 ↗
  • 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. PubMed 16305351 ↗
  • Christopoulos 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04056247
Lead sponsor
OncoHost Ltd.
Responsible party
Sponsor
First posted
Aug 14, 2019
Start date
Oct 1, 2019
Primary completion
Oct 1, 2029 (estimated)
Completion
Oct 1, 2029 (estimated)
Last update
Oct 15, 2025

Study contacts

Alona Zer, MD
principal investigator · Rambam Health Care Campus
Michal Lotem, MD
principal investigator · Hadassah Medical Organization
Jair Bar, MD
principal investigator · Sheba Medical Center
Maya Gottfried, MD
principal investigator · Meir Medical Center
Abed Agbaria, MD
principal investigator · Bnai Zion Medical Center
Ido Wolf, MD
principal investigator · Tel-Aviv Sourasky Medical Center
Mahmud Abu-Amana, MD
principal investigator · haemek medical center
Rivka Katsenelson, MD
principal investigator · Kaplan Medical Center
Alexander Yakobson, MD
principal investigator · Soroka University Medical Center
Tatiana Harkovsky, MD
principal investigator · Barzilai Medical Center
Mor Moskovitz, MD
principal investigator · Rabin Medical Center
Elizabeta Dudnik, MD
principal investigator · Assuta Medical Center
Raya Leibowitz, MD
principal investigator · Assaf-Harofeh Medical Center
Adam Berger, MD
principal investigator · Rutgers Cancer Institute
Jose Lutzky, MD
principal investigator · University of Miami
Antony Magliocco, MD
principal investigator · Protean BioDiagnostics
Gillian Price, MD
principal investigator · Aberdeen Royal Infirmary
Helen Cheley
principal investigator · Swansea Bay UHB - Cancer Institute
Louise Medley, MD
principal investigator · Torbay and South Devon NHS foundation
Tom Geldart, MD
principal investigator · Royal Bournemouth General Hospital Dorset
Anirban Chatterjee, MD
principal investigator · The Shrewsbury and Telford Hospital
Sean Brown, MD
principal investigator · Gloucestershire Hospitals NHS Foundation Trust
Andreas Polychronis, MD
principal investigator · Mount Vernon Cancer Centre
Andreas Polychronis, MD
principal investigator · Lister Hospital
Ari VanderWalde, MD
principal investigator · West Clinic
Davika Das, MD
principal investigator · VAHCS Birmingham
Alison Brewster, MD
principal investigator · Withybush Hospital Hawl Dda University Health Board
Adam Hassani
principal investigator · Sunderland Royal Hospital
Adam Hassani, MD
principal investigator · South Tyneside District
Andrew Conn, MD
principal investigator · Bradford Teaching Hospitals
Yanyan Lou, MD
principal investigator · Mayo Clinic
Igor Puzanov, MD
principal investigator · Roswell Park
Ernesto Bustinza, MD
principal investigator · Florida Cancer Specialists and Research Institute
Huang Quillan, MD
principal investigator · Michael E. DeBakey VA Medical Center
Ronnie Shapira Frommer, MD
principal investigator · Sheba Medical Center
Astrid Ammendola, MD
principal investigator · Asklepios Klinik Gauting GmbH
Petros Christopoulos, MD
principal investigator · Thoraxklinik-Heidelberg gGmbH
Marina Messinger, MD
principal investigator · Northwest Community Healthcare
Sunil Patel, MD
principal investigator · CHRISTUS St. Michael Health System
Bharat P Jenigiri, MD
principal investigator · Physicians Clinic of Iowa
David Vecente, MD
principal investigator · Hospital Universitario Virgen Macarena
Eugenie Younger, MD
principal investigator · Gloucestershire Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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