Prospective external control cohort for newly diagnosed advanced EGFR‑mutant NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The protocol enrolls adults with locally advanced or metastatic NSCLC harboring common EGFR mutations (exon 19 deletion or exon 21 L858R) diagnosed on or after January 1, 2024 and collects standardized data at baseline, during treatment, and at therapy discontinuation. Approximately 30% of participants who enroll before starting osimertinib will undergo imaging at predefined, standardized intervals. Key exclusions include ECOG performance status ≥2 and prior treatment with osimertinib, amivantamab, or lazertinib; additional analytic eligibility will follow the COPERNICUS statistical analysis plan. Enrollment is being conducted at three U.S. cancer centers and the cohort is intended to serve as a prospective external control for comparative analyses.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

* Be ≥18 years of age at the time of informed consent
* Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.

EXCLUSION CRITERIA

* ECOG≥2 at diagnosis of advanced or metastatic NSCLC
* Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.

Where it's running

• Pacific Cancer Care
  Monterey, California, United States Recruiting
• Torrance Memorial Physician Network-Cancer Care
  Torrance, California, United States Recruiting
• John Muir Health
  Walnut Creek, California, United States Recruiting
• Bayhealth Cancer Center- Kent
  Dover, Delaware, United States Recruiting
• Bayhealth Cancer Center- Sussex
  Milford, Delaware, United States Recruiting
• Kootenai Clinic Cancer Services Coeur d'Alene
  Coeur d'Alene, Idaho, United States Recruiting

Study contacts

• Study coordinator: N-Power Medicine Support
• Email: support@npowermedicine.com
• Phone: 1-833-467-6734

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.