Actively Recruiting
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
Led by Shanghai Chest Hospital · Updated on 2025-11-26
250
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
S
Shanghai Chest Hospital
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Ability to provide plasma samples at baseline.
- Newly diagnosed, histologically confirmed locally advanced or metastatic non-squamous NSCLC with sensitizing EGFR mutations (Exon 19 deletion or 21 L858R).
- Disease classified as stage IIIB, IIIC, IV, or recurrent NSCLC not suitable for curative surgery or radiotherapy.
- Detectable EGFR mutation in plasma ctDNA by central testing at screening.
- Untreated advanced NSCLC intending to receive osimertinib plus chemotherapy as first-line treatment.
- Previous adjuvant or neoadjuvant therapies completed at least 12 months before study treatment.
- Stable and asymptomatic central nervous system metastases for at least 2 weeks if present.
- At least one measurable lesion not previously irradiated suitable for repeated measurements.
- Patients with hepatitis B allowed if meeting specific viral and liver function criteria and receiving antiviral treatment.
- Patients with HIV allowed if meeting specific viral load and immune status criteria.
- Females of childbearing potential must use effective contraception and have a negative pregnancy test or documented non-childbearing status.
- Male participants must use barrier contraception.
You will not qualify if you...
- History of interstitial lung disease, drug-induced lung disease, or radiation pneumonitis requiring steroids.
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding, or active infections such as hepatitis C or uncontrolled hepatitis B.
- Cardiac abnormalities including prolonged QTc interval, serious arrhythmias, or electrolyte imbalances increasing cardiac risk.
- Inadequate bone marrow or organ function as indicated by specific laboratory test thresholds.
- Concurrent or recent other active malignancies requiring treatment within 2 years.
- Unresolved toxicities from prior therapies above grade 1 except alopecia and certain neuropathies.
- Severe gastrointestinal issues preventing drug absorption.
- Prior systemic treatment for advanced NSCLC except certain allowed prior therapies completed at least 12 months prior.
- Prior EGFR-TKI treatment.
- Major surgery within 4 weeks before study drug administration.
- Extensive palliative radiotherapy to bone marrow within 4 weeks before study drug.
- Use of strong CYP3A4 inducers that cannot be stopped before study drug.
- Participation in another clinical trial with investigational drug within 5 half-lives or 3 months before study start.
- Hypersensitivity to osimertinib or related drugs.
- Contraindications to pemetrexed or platinum chemotherapy.
- Breastfeeding women.
- Involvement in study planning or conduct.
- Investigator judgment deeming participant unsuitable or unlikely to comply with protocol requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
S
Shun Lu, PhD
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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