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

ConditionsNon Small Cell Lung CancerHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOncoHost Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of informed consent prior to any study-specific procedures.

Male or female aged at least 18 years.

ECOG PS - 0/1-2.

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • blood, stool and tissue samples collection

    Other intervention

    blood, stool and tissue samples collection before and during the treatment, as applicable

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: Non-operable NSCLC patients receiving ICI therapy1 intervention
Group B: Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy1 intervention
Group C: Healthy volunteers1 intervention

Trial outcomes

Primary outcomes

1

Overall response (OR)

OR as defined by RECIST 1.1 or any other validated clinical scale for response

Time frame
month 3
2

Overall response (OR)

OR as defined by RECIST 1.1 or any other validated clinical scale for response

Time frame
month 6
3

Overall response (OR)

OR as defined by RECIST 1.1 or any other validated clinical scale for response

Time frame
month 9
4

Overall response (OR)

OR as defined by RECIST 1.1 or any other validated clinical scale for response

Time frame
month 12

Secondary outcomes

Other outcomes

1

Progression Free Survival (PFS)

Documentation of Progression Free Survival (PFS) duration

Time frame
From date of enrollment until the date of first documented progression, assessed up to 100 months
2

Overall Survival (OS)

Documentaion of Overall Survival (OS) duration

Time frame
From date of enrollment until the date of death from any cause, assessed up to 100 month
3

Adverse Events (AE)

AE, as reported by the patients

Time frame
3 months
4

Adverse Events (AE)

AE, as reported by the patients

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OncoHost Ltd.

Lead sponsor

Source ClinicalTrials.gov
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