Non Small Cell Lung CancerPROPHETICNCT05736029
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
An observational study of Non Small Cell Lung Cancer and Healthy, run by OncoHost Ltd. at 1 site in United States.
Trial summary
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients. The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer, Healthy
- What is being tested?
- blood, stool and tissue samples collection
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population comprises 3 sub-populations: Cohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI) therapy [any combination of ICI / ICI ±Chemotherapy, and any line of treatment]. Cohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant setting. Cohort 3 - Sex and aged matched non-diseased volunteers.
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.
Who cannot join
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
- Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott and White Research Institute
Dallas, Texas, 75204
Pappu Himabindu, Himabindu.Pappu@BSWHealth.org
Ronan J Kelly, MD MBA
About this study
Official title: PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.
The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.
Patients will provide biological samples before and during their treatment, and clinical data will be collected.
Read the detailed description
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:
- Response to treatment
- Clinical benefit parameters such as PFS and OS.
- Adverse events to immune check inhibitor therapy
- Biological mechanisms involved in response or resistance to immune check inhibitor therapy.
Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.
Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.
Samples will be analysed as follows -
- Proteomic features (Plasma proteomics)
- Epigenetic patterns (cell free DNA)
- ctDNA mutation analysis
- PBMC subpopulations
- Microbiome profiling (Stool)
- Conditions
- Non Small Cell Lung Cancer, Healthy
- Being tested
- blood, stool and tissue samples collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood, stool and tissue samples collectionOther
blood, stool and tissue samples collection before and during the treatment, as applicable
| Study group | Role | What they receive |
|---|---|---|
| Non-operable NSCLC patients receiving ICI therapy | Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care Receives: Other: blood, stool and tissue samples collection | |
| Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy | Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting Receives: Other: blood, stool and tissue samples collection | |
| Healthy volunteers | Sex and aged matched non-diseased volunteers Receives: Other: blood, stool and tissue samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 3
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 6
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 9
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 12
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 15
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 18
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 21
Overall response (OR)
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Measured: month 24
Plasma proteomic profile
Plasma proteins measurments
Measured: Baseline, pre treatment
Plasma proteomic profile
Plasma proteins measurments
Measured: 2(+/-1) weeks from first treatment
Plasma proteomic profile
Plasma proteins measurments
Measured: 3 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 6 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 9 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 12 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 15 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 18 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 21 months
Plasma proteomic profile
Plasma proteins measurments
Measured: 24 months
Epigenetic patterns
Characterization of Cell free DNA
Measured: Baseline, pre treatment
Epigenetic patterns
Characterization of Cell free DNA
Measured: 2(+/-1) weeks from first treatment
Epigenetic patterns
Characterization of Cell free DNA
Measured: 12 months
Epigenetic patterns
Characterization of Cell free DNA
Measured: 24 months
ctDNA mutation analysis
ctDNA mutation analysis
Measured: immediately after surgery
Microbiome profiling
PBMC subpopulations exploration
Measured: Baseline, pre treatment
Microbiome profiling
PBMC subpopulations exploration
Measured: 2(+/-1) weeks from first treatment
Microbiome profiling
PBMC subpopulations exploration
Measured: 12 months
Microbiome profiling
PBMC subpopulations exploration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Nov 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoHost Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronan J Kelly, MD MBA, Principal investigator, Chief of Oncology Baylor Scott & White Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736029
- Sponsor's protocol ID
- OH-HRPP-002
- Acronym
- PROPHETIC
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
- ClinicalTrials.gov ID
- NCT05736029
- Acronym / sponsor ID
- PROPHETIC / OH-HRPP-002
- Conditions
- Non Small Cell Lung Cancer, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- OncoHost Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.
The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.
Patients will provide biological samples before and during their treatment, and clinical data will be collected.
Detailed description
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:
- Response to treatment
- Clinical benefit parameters such as PFS and OS.
- Adverse events to immune check inhibitor therapy
- Biological mechanisms involved in response or resistance to immune check inhibitor therapy.
Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.
Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.
Samples will be analysed as follows -
- Proteomic features (Plasma proteomics)
- Epigenetic patterns (cell free DNA)
- ctDNA mutation analysis
- PBMC subpopulations
- Microbiome profiling (Stool)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-operable NSCLC patients receiving ICI therapy | – | Other: blood, stool and tissue samples collectionPatients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care |
| Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy | – | Other: blood, stool and tissue samples collectionPatients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting |
| Healthy volunteers | – | Other: blood, stool and tissue samples collectionSex and aged matched non-diseased volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population comprises 3 sub-populations: Cohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI) therapy [any combination of ICI / ICI ±Chemotherapy, and any line of treatment]. Cohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant setting. Cohort 3 - Sex and aged matched non-diseased volunteers.
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study-specific procedures.
- Male or female aged at least 18 years.
- ECOG PS - 0/1-2.
Key exclusion criteria (2 listed)
- Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
- Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood, stool and tissue samples collectionblood, stool and tissue samples collection before and during the treatment, as applicable | Other | Healthy volunteers, Non-operable NSCLC patients receiving ICI therapy, Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy |
Primary outcome
Overall response (OR)
Time frame: month 3
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 6
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 9
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 12
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 15
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 18
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 21
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Overall response (OR)
Time frame: month 24
OR as defined by RECIST 1.1 or any other validated clinical scale for response
Plasma proteomic profile
Time frame: Baseline, pre treatment
Plasma proteins measurments
Plasma proteomic profile
Time frame: 2(+/-1) weeks from first treatment
Plasma proteins measurments
Plasma proteomic profile
Time frame: 3 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 6 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 9 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 12 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 15 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 18 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 21 months
Plasma proteins measurments
Plasma proteomic profile
Time frame: 24 months
Plasma proteins measurments
Epigenetic patterns
Time frame: Baseline, pre treatment
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 2(+/-1) weeks from first treatment
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 12 months
Characterization of Cell free DNA
Epigenetic patterns
Time frame: 24 months
Characterization of Cell free DNA
ctDNA mutation analysis
Time frame: immediately after surgery
ctDNA mutation analysis
Microbiome profiling
Time frame: Baseline, pre treatment
PBMC subpopulations exploration
Microbiome profiling
Time frame: 2(+/-1) weeks from first treatment
PBMC subpopulations exploration
Microbiome profiling
Time frame: 12 months
PBMC subpopulations exploration
Microbiome profiling
Time frame: 24 months
PBMC subpopulations exploration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Solid Tumor, Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronan J Kelly, MD MBA principal investigator
Chief of Oncology Baylor Scott & White Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Healthy, run by OncoHost Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galit Yahalom, PhD (97248537557, galit@oncohost.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (OR) (time frame: month 3). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.