🏛️ Verified NIH Record • Updated 2026-08-03

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) (NCT05170204)

A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) NSCLC staging system.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (54 items).

Location: Northwest Cancer Specialists, P.C. — Tigard, Oregon

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria (All Cohorts):
  • Any history of previous NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  • Any evidence of Stage IV disease, including, but not limited to, the following: pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases
  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease): when pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; participants with exudative pleural effusions are excluded regardless of cytology; participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible
  • NSCLC known to have a known or likely oncogenic-driver mutation in the epidermal growth factor receptor (EGFR) gene, as identified by site local testing or Sponsor central testing
  • Liver disease, characterized by any of the following: impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease, such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
  • Positive hepatitis B surface antigen (HBsAg) test at screening
  • Participants known to be positive for hepatitis C virus (HCV) antibody (Ab) are excluded with the following exception: participants who are HCV Ab positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution are eligible
  • HIV infection: participants are excluded if not well-controlled as defined by the protocol
  • Known active tuberculosis
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan
  • Grade ≥ 2 pneumonitis from prior cCRT or sCRT

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

  • Northwest Cancer Specialists, P.C. — Tigard, Oregon
  • Hillman Cancer Center — Pittsburgh, Pennsylvania
  • Peter MacCallum Cancer Centre — Melbourne, Victoria
  • One Clinical Research — Nedlands, Western Australia
  • UZ Gent — Ghent,
  • Hospital de Cancer de Barretos — Barretos, São Paulo
  • Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo
  • RedSalud Vitacura — Santiago,
  • Hunan Cancer Hospital — Changsha,
  • Xinqiao Hospital of Third Military Medical University — Chongqing,
  • Shandong Cancer Hospital — Jinan,
  • Shanghai Pulmonary Hospital — Shanghai,
  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo — Bogota, D.C.,
  • Hospital Universitario San Ignacio — Bogotá,
  • Centre Francois Baclesse — Caen,
  • Centre Leon Berard — Lyon,
  • Hopital Nord — Marseille,
  • Helios Klinikum Emil von Behring GmbH — Berlin,
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola — Meldola, Emilia-Romagna
  • Asst Grande Ospedale Metropolitano Niguarda — Milan, Lombardy
  • NHO Kyushu Cancer Center — Fukuoka,
  • Kurume University Hospital — Fukuoka,
  • Kobe City Medical Center General Hospital — Hyōgo,
  • Kagoshima University Hospital — Kagoshima,
  • Kumamoto University Hospital — Kumamoto,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗