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Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy

NCT05715229 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-02-18

No results posted yet for this study

Summary

This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Nivolumab

Immunotherapy

DRUG

Ipilimumab

Immunotherapy

DRUG

Carboplatin

Chemotherapy

DRUG

Paclitaxel

Chemotherapy

DRUG

Pemetrexed

Chemotherapy

Sponsors & Collaborators

  • MedSIR

    collaborator OTHER

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Martin Gutierrez, MD · Hackensack Meridian Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2027-04-28
Completion
2027-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05715229 on ClinicalTrials.gov