Recruiting NCT07174388
An External Control Arm Study in Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients
Overview
A study to create control arms using current and future information in patients with lung cancer.
Primary outcome measures
- Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies [Time frame: September 2025-April 2029]
Secondary outcome measures (1)
- Assess Progression Free Survival (PFS), Overall Survival (OS), and Time to Next Treatment (TTNT) by cohort in patients with metastatic NSCLC initiating second or third line treatment with NCCN recommended therapies. [Time frame: September 2025-April2029]
Eligibility criteria
Inclusion criteria
- > 18 years of age at the time of informed consent
- Pathologically confirmed locally advanced or metastatic NSCLC
- ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.
- Life expectancy of more than 3 months
- Able to understand and sign informed consent
- Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)
\*see protocol for cohort specific inclusion criteria\*
Exclusion criteria
- Actively on a clinical trial of an investigational agent
- Currently receiving active systemic therapy for another malignancy
- Eligible for treatment with curative intent
\*see protocol for cohort specific exclusion criteria\*
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- Pacific Cancer Care — Monterey
- Bayhealth Medical Center, Kent Campus — Dover
- Bayhealth Medical Center- Sussex Campus — Milford
- Northwest Oncology and Hematology — Barrington
- Northwest Oncology and Hematology — Elk Grove
- Northwest Oncology and Hematology — Hoffman Estates
- Northwest Oncology and Hematology — Rolling Meadows
- Oncology Consultants — Houston
Identifiers
NCT: NCT07174388 · NPM-004