Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!

a study on Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Surbhi Singhal, MD (ucdavis)

Description

Summary

This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.

Details

Participants will be randomized to an intervention arm or a standard of care (SOC) arm. Participants in the intervention arm will undergo pretreatment assessment with PROphet Clinical Benefit (CB) and the Cancer and Aging Research Group Toxicity Tool (CARG-TT); data from the assessments will be used to select systemic therapy, which can be any SOC treatment that incorporates a Programmed death-ligand 1 (PD-(L)1) antibody with or without chemotherapy and/or with or without Cytotoxic T-lymphocyte associated protein 4 (CTLA4) antibody. Participants in the SOC arm will undergo SOC biomarker assessment and subsequent selection of SOC systemic therapy. The primary endpoint is 12-month progression free survival (PFS). The findings will be stratified according to participant performance status and tumor PD-L1 score. The hypothesis is that risk-adapted, proteomic-guided systemic therapy will improve PFS among patients with previously untreated advanced NSCLC compared to SOC systemic therapy.

Keywords

Non-small Cell Lung Cancer Stage IIIC, Non-small Cell Lung Cancer Stage IV, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Unresectable, Non-Small-Cell Lung Carcinoma, Standard of Care, Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment., Systemic immune checkpoint inhibitor (ICI)-based therapy informed by PROphet CB and CARG-TT

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent.
  • Age ≥18 years at the time of consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%).
  • Ability to understand and willingness to sign the informed consent form (ICF).
  • Stated ability and willingness to adhere to all protocol requirements while on study

You CAN'T join if...

  • Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1.
  • Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion.
  • Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion.
  • Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study

Location

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07250477
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 56 study participants
Last Updated
Contact us about this trial