Plasma Sample Collection for Lung Cancer
(PROPHETIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to develop a tool to predict patient responses to cancer treatments by analyzing blood proteins. It focuses on individuals with advanced lung cancer or melanoma who are receiving specific therapies, including immune checkpoint inhibitors (ICI) and chemotherapy. Those with Stage III or IV non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or malignant melanoma undergoing these treatments may qualify. Participants will have their blood collected before and during treatment to help refine this predictive tool. As an unphased trial, this study offers the opportunity to contribute to groundbreaking research that could enhance future cancer treatment predictions.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this algorithm is safe for predicting patient outcomes?
Research has shown that immune checkpoint inhibitors (ICI) are usually well-tolerated by patients, though they can cause some side effects. These drugs have proven very effective in treating non-small cell lung cancer (NSCLC) and melanoma. Some patients may experience side effects affecting different organs, but these are often manageable.
Chemotherapy, a long-standing treatment option, can cause side effects like nausea and tiredness, but these are usually temporary and manageable with medication. Studies indicate that combining chemotherapy with ICI can improve results, although it may also increase the risk of side effects.
Targeted therapy, often used for melanoma, has shown promise in research. Like other treatments, it can have side effects, which usually depend on the specific drug used.
Overall, these treatments are considered safe with proper monitoring and care. Patients interested in joining a clinical trial should consult their healthcare provider about potential side effects to understand what to expect and how to manage them.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how patients with advanced stages of cancer respond to treatments by analyzing their plasma samples. Unlike traditional methods that primarily focus on the cancer itself, this approach looks at the body's response, potentially leading to more personalized and effective treatment plans. By understanding individual reactions to therapies like immune checkpoint inhibitors (ICIs) and chemotherapy, the trial could pave the way for better prediction of treatment success and optimization of therapeutic strategies. This could mean more targeted and efficient treatments for patients with Stage III and IV cancers, such as non-small cell lung cancer (NSCLC), malignant melanoma, and small cell lung cancer (SCLC).
What evidence suggests that this trial's treatments could be effective for NSCLC and malignant melanoma?
This trial will examine the effects of immune checkpoint inhibitors (ICIs) across various cancer stages. Research has shown that ICIs can be very effective for certain cancer types. For individuals with advanced melanoma, these treatments have been linked to improved survival rates. ICIs assist the immune system in identifying and destroying cancer cells. They also show promise for treating advanced stages of non-small cell lung cancer (NSCLC), although results can vary among individuals. While outcomes may differ, ICIs remain an important treatment option for these cancer stages. Overall, ICIs offer hope by enhancing the body's natural ability to combat cancer.678910
Who Is on the Research Team?
Eugenie Younger, MD
Principal Investigator
Gloucestershire Hospitals NHS Foundation Trust
Sean Brown, MD
Principal Investigator
Gloucestershire Hospitals NHS Foundation Trust
Bharat P Jenigiri, MD
Principal Investigator
Physicians Clinic of Iowa
Huang Quillan, MD
Principal Investigator
Michael E. DeBakey VA Medical Center
Astrid Ammendola, MD
Principal Investigator
Asklepios Klinik Gauting GmbH
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
Mor Moskovitz, MD
Principal Investigator
Rabin Medical Center
Jose Lutzky, MD
Principal Investigator
University of Miami
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
Ari VanderWalde, MD
Principal Investigator
West Clinic
Petros Christopoulos, MD
Principal Investigator
Thoraxklinik-Heidelberg gGmbH
Marina Messinger, MD
Principal Investigator
Northwest Community Healthcare
David Vecente, MD
Principal Investigator
Hospital Universitario Virgen Macarena
Alexander Yakobson, MD
Principal Investigator
Soroka University 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
Antony Magliocco, MD
Principal Investigator
Protean BioDiagnostics
Gillian Price, MD
Principal Investigator
Aberdeen Royal Infirmary
Anirban Chatterjee, MD
Principal Investigator
The Shrewsbury and Telford Hospital
Andreas Polychronis, MD
Principal Investigator
Lister Hospital
Adam Hassani, MD
Principal Investigator
South Tyneside District
Andrew Conn, MD
Principal Investigator
Bradford Teaching Hospitals
Yanyan Lou, MD
Principal Investigator
Mayo 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
Igor Puzanov, MD
Principal Investigator
Roswell Park
Ernesto Bustinza, MD
Principal Investigator
Florida Cancer Specialists and Research Institute
Ronnie Shapira Frommer, MD
Principal Investigator
Sheba Medical Center
Sunil Patel, MD
Principal Investigator
CHRISTUS St. Michael Health System
Tatiana Harkovsky, MD
Principal Investigator
Barzilai Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care treatment, including Immunotherapy or Immunotherapy + Chemotherapy, and provide blood samples for algorithm development
Follow-up
Participants are monitored for safety and effectiveness after treatment, including collection of ORR, AE, PFS, OS, and DOR data
What Are the Treatments Tested in This Trial?
Interventions
- Plasma sample collection
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
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).
Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.
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.
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.
Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
OncoHost Ltd.
Lead Sponsor
Citations
Immune Checkpoint Inhibitors for the Treatment of ...
There has been no improvement in outcome for patients with unresectable locally advanced (stage III) non–small cell lung cancer (NSCLC) for more than 10 years.
Immune checkpoint inhibitors in metastatic melanoma ...
Overall, their study suggested that ipilimumab treatment improved the survival outcomes of patients with unresectable stage III or IV melanomas, ...
Immune Checkpoint Inhibitor Therapy for Metastatic Melanoma
This review summarizes current ICIs for melanoma and the factors involved in resistance to the treatment.
Immune checkpoint inhibitors in melanoma
Immune checkpoint inhibitors target the dysfunctional immune system, to induce cancer-cell killing by CD8-positive T cells.
Immunotherapy in unresectable stage III non-small-cell ...
In this review, we present the results of clinical trials investigating immune therapy in unresectable stage III NSCLC and discuss in-depth ...
Stage III Non-Small-Cell Lung Cancer - PubMed Central - NIH
Although the survival rate is still poor (13–36% according to the different subgroups), stage III NSCLC can be treated with a curative intent. For this reason, ...
Safety and Efficacy of SCLC Treatments Based on Trial Data
Panelists review key clinical trial data demonstrating the efficacy and safety of chemo-immunotherapy regimens in extensive-stage small cell ...
Treatment Choices for Non-small Cell Lung Cancer, by Stage
For stage IIIA lung cancers that is not able to be surgically removed, treatment usually starts with chemo, often combined with radiation ...
The evolving landscape of stage III unresectable non-small ...
This review aims to describe the evolving landscape of unresectable stage III NSCLC and provides an updated overview of the available evidence.
Non-Small Cell Lung Cancer Treatment (PDQ®) - NCI
Non-small cell lung cancer (NSCLC) treatment options include surgery, chemotherapy, radiation therapy, targeted therapy, and immunotherapy.
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