Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04253964

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Led by Wake Forest University Health Sciences · Updated on 2026-03-19

105

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.

CONDITIONS

Official Title

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a cytological or histological diagnosis of non-small cell lung cancer that is metastatic or unresectable for which standard curative measures do not exist.
  • No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early-stage disease.
  • At least 18 years old.
  • ECOG performance status of 0-2, as determined by the treating physician in the consult note.
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count 651,000/mcL
  • platelets 65100,000/mcL
  • Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document.
Not Eligible

You will not qualify if you...

  • Nonsmall cell lung cancer known to have tumor activating alterations with first line targeted therapy indications (EGFR, ALK, ROS1, B-Raf mutations).
  • Known active autoimmune disease requiring systemic treatment in the past 2 years.
  • History of (non-infectious) pneumonitis requiring systemic corticosteroids.
  • Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance.
  • Pregnant women.
  • Breastfeeding women due to potential risks from chemotherapy treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27105

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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