Recruiting

Oncology Multiomics

Sponsor:

OncoHost Ltd.

Code:

NCT05736029

Conditions

Non Small Cell Lung Cancer

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

blood, stool and tissue samples collection

Study Details

Brief 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 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.

Conditions

Non Small Cell Lung Cancer

Healthy

Study ID

NCT05736029

Start date

Nov 7, 2022

Status verified date

Feb, 2023

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Healthy volunteers

Sex and aged matched non-diseased volunteers

Interventions

blood, stool and tissue samples collection

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

Primary outcome measure

  • Overall response (OR) [ Time Frame: month 3 ]
  • Overall response (OR) [ Time Frame: month 6 ]
  • Overall response (OR) [ Time Frame: month 9 ]
  • Overall response (OR) [ Time Frame: month 12 ]
  • Overall response (OR) [ Time Frame: month 15 ]
  • Overall response (OR) [ Time Frame: month 18 ]
  • Overall response (OR) [ Time Frame: month 21 ]
  • Overall response (OR) [ Time Frame: month 24 ]
  • Plasma proteomic profile [ Time Frame: Baseline, pre treatment ]
  • Plasma proteomic profile [ Time Frame: 2(+/-1) weeks from first treatment ]
  • Plasma proteomic profile [ Time Frame: 3 months ]
  • Plasma proteomic profile [ Time Frame: 6 months ]
  • Plasma proteomic profile [ Time Frame: 9 months ]
  • Plasma proteomic profile [ Time Frame: 12 months ]
  • Plasma proteomic profile [ Time Frame: 15 months ]
  • Plasma proteomic profile [ Time Frame: 18 months ]
  • Plasma proteomic profile [ Time Frame: 21 months ]
  • Plasma proteomic profile [ Time Frame: 24 months ]
  • Epigenetic patterns [ Time Frame: Baseline, pre treatment ]
  • Epigenetic patterns [ Time Frame: 2(+/-1) weeks from first treatment ]
  • Epigenetic patterns [ Time Frame: 12 months ]
  • Epigenetic patterns [ Time Frame: 24 months ]
  • ctDNA mutation analysis [ Time Frame: immediately after surgery ]
  • Microbiome profiling [ Time Frame: Baseline, pre treatment ]
  • Microbiome profiling [ Time Frame: 2(+/-1) weeks from first treatment ]
  • Microbiome profiling [ Time Frame: 12 months ]
  • Microbiome profiling [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Galit Yahalom, PhD

97248537557galit@oncohost.com

Shani Raveh Shoval, PhD

97248537557shani@oncohost.com

Locations

Baylor Scott and White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Contacts

Pappu Himabindu

Himabindu.Pappu@BSWHealth.org

Principal Investigator:

Ronan J Kelly, MD MBA

More Information

Sponsor

OncoHost Ltd.

Last update posted

Feb 21, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OncoHost Ltd. on 2023-02-21.