Actively Recruiting
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
Led by AstraZeneca · Updated on 2026-04-08
60
Participants Needed
20
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).
CONDITIONS
Official Title
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older who can provide informed consent
- Diagnosed with locally advanced, unresectable Stage III NSCLC with nonsquamous, squamous, or adenosquamous pathology
- Confirmed presence of common EGFR mutations (exon 19 deletion or L858R), alone or with other mutations
- WHO performance status of 0, 1, or 2 without recent deterioration
- Eligible for and planning to receive radiation therapy
- Refusal or ineligibility for chemotherapy as assessed by a physician
- Minimum life expectancy of more than 12 weeks at study start
- At least one measurable lesion of at least 10 mm on CT or MRI suitable for repeated measurement
- No prior chemotherapy, radiation, immunotherapy, targeted therapy, or investigational treatment for locally advanced Stage III NSCLC
- Capability to comply with study requirements and provide informed consent
You will not qualify if you...
- Presence of small cell or mixed small-cell and non-small cell lung cancer
- History or evidence of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids
- Severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding
- Chronic gastrointestinal conditions affecting drug absorption or inability to swallow osimertinib
- History of other primary cancers within 2 years except certain treated skin or in situ cancers
- Cardiac issues including mean resting QTc over 470 msec
- Inadequate bone marrow or organ function
- Unresolved toxicities from prior treatments above CTCAE Grade 1 except alopecia or certain neuropathies
- Prior EGFR-TKI therapy
- Recent major surgery or trauma within 4 weeks before starting the study
- Participation in another clinical study with investigational treatments within 4 weeks
- Known hypersensitivity to osimertinib or radiotherapy components
- Involvement in study planning or conduct
- Judged unlikely to comply with study procedures
- Previous enrollment in this study
- For women: currently pregnant or breastfeeding; breastfeeding must stop from enrollment until 6 weeks after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Research Site
Beijing, China, 100021
Not Yet Recruiting
2
Research Site
Beijing, China, 100730
Not Yet Recruiting
3
Research Site
Changchun, China, 130021
Not Yet Recruiting
4
Research Site
Changsha, China, 410013
Not Yet Recruiting
5
Research Site
Chengdu, China, 610041
Not Yet Recruiting
6
Research Site
Foshan, China, 528000
Not Yet Recruiting
7
Research Site
Fuzhou, China, 350011
Not Yet Recruiting
8
Research Site
Guangzhou, China, 510060
Not Yet Recruiting
9
Research Site
Guangzhou, China, 510100
Actively Recruiting
10
Research Site
Harbin, China, 150081
Not Yet Recruiting
11
Research Site
Hefei, China, 230031
Not Yet Recruiting
12
Research Site
Jinan, China, 250021
Not Yet Recruiting
13
Research Site
Kunming, China, 650118
Not Yet Recruiting
14
Research Site
Nanchang, China, 330006
Not Yet Recruiting
15
Research Site
Qingdao, China, 110016
Not Yet Recruiting
16
Research Site
Shanghai, China, 200120
Not Yet Recruiting
17
Research Site
Shanghai, China, 200433
Not Yet Recruiting
18
Research Site
Taiyuan, China, 030000
Not Yet Recruiting
19
Research Site
Wenzhou, China, 325000
Actively Recruiting
20
Research Site
Xuzhou, China, 221000
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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