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NCT07058519
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
Phase 2 trial testing Osimertinib-based adaptive treatment in Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) in 250 participants. Currently enrolling.
24 January 2029
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 23 September 2025 |
| Primary completion | 24 January 2029 |
| Estimated completion | 24 January 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Osimertinib-based adaptive treatment — full drug profile →
- Osimertinib 80 MG — full drug profile →
Conditions studied
- Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) — all drugs for Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC) →
Sponsor
Shanghai Chest Hospital
Who can join
18 and older, any sex, with Locally Advanced or Metastatic EGFRm Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this adaptive, interventional study is to assess the efficacy and safety of osimertinib-based adaptive treatment based on ctDNA dynamic monitoring in locally advanced or metastatic EGFRm NSCLC participants with ctDNA EGFRm clearance after osimertinib plus chemotherapy. The main questions it aims to answer are: 1) PFS during adaptive treatment period in Cohort 1 defined as from initiation of Osimertinib in adaptive period to progression per investigator assessment; 2) Time from initiation of osimertinib in adaptive period to first ctDNA EGFRm relapse or death
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07058519
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shanghai Chest Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07058519 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Chest Hospital
- Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07058519.
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