NCT05736029

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2022Jun 2028

Study Start

First participant enrolled

November 7, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5.2 years

First QC Date

January 31, 2023

Last Update Submit

February 9, 2023

Conditions

Non Small Cell Lung CancerHealthy

Outcome Measures

Primary Outcomes (27)

  • Overall response (OR)

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

    month 3

  • Overall response (OR)

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

    month 6

  • Overall response (OR)

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

    month 9

  • Overall response (OR)

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

    month 12

  • Overall response (OR)

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

    month 15

  • Overall response (OR)

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

    month 18

  • Overall response (OR)

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

    month 21

  • Overall response (OR)

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

    month 24

  • Plasma proteomic profile

    Plasma proteins measurments

    Baseline, pre treatment

  • Plasma proteomic profile

    Plasma proteins measurments

    2(+/-1) weeks from first treatment

  • Plasma proteomic profile

    Plasma proteins measurments

    3 months

  • Plasma proteomic profile

    Plasma proteins measurments

    6 months

  • Plasma proteomic profile

    Plasma proteins measurments

    9 months

  • Plasma proteomic profile

    Plasma proteins measurments

    12 months

  • Plasma proteomic profile

    Plasma proteins measurments

    15 months

  • Plasma proteomic profile

    Plasma proteins measurments

    18 months

  • Plasma proteomic profile

    Plasma proteins measurments

    21 months

  • Plasma proteomic profile

    Plasma proteins measurments

    24 months

  • Epigenetic patterns

    Characterization of Cell free DNA

    Baseline, pre treatment

  • Epigenetic patterns

    Characterization of Cell free DNA

    2(+/-1) weeks from first treatment

  • Epigenetic patterns

    Characterization of Cell free DNA

    12 months

  • Epigenetic patterns

    Characterization of Cell free DNA

    24 months

  • ctDNA mutation analysis

    ctDNA mutation analysis

    immediately after surgery

  • Microbiome profiling

    PBMC subpopulations exploration

    Baseline, pre treatment

  • Microbiome profiling

    PBMC subpopulations exploration

    2(+/-1) weeks from first treatment

  • Microbiome profiling

    PBMC subpopulations exploration

    12 months

  • Microbiome profiling

    PBMC subpopulations exploration

    24 months

Other Outcomes (10)

  • Progression Free Survival (PFS)

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

  • Overall Survival (OS)

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

  • Adverse Events (AE)

    3 months

  • +7 more other outcomes

Study Arms (3)

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

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

Other: blood, stool and tissue samples collection

Healthy volunteers

Sex and aged matched non-diseased volunteers

Other: blood, stool and tissue samples collection

Interventions

blood, stool and tissue samples collectionOTHER

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

Healthy volunteersNon-operable NSCLC patients receiving ICI therapyOperable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Provision of informed consent prior to any study-specific procedures.
  • Male or female aged at least 18 years.
  • ECOG PS - 0/1-2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Scott and White Research Institute

Dallas, Texas, 75204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. plasma samples 2. PBMCs 3. Stool samples 4. Tissue samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen CollectionDefecation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Ronan J Kelly, MD MBA

    Chief of Oncology Baylor Scott & White Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Galit Yahalom, PhD

CONTACT

97248537557galit@oncohost.com

Shani Raveh Shoval, PhD

CONTACT

97248537557shani@oncohost.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 21, 2023

Study Start

November 7, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)