Actively Recruiting
A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2022-06-16
150
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the efficacy and safety of Almonertinib versus placebo following chemoradiation in patients with stage III unresectable epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC).
CONDITIONS
Official Title
A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent before any study procedures.
- Male or female aged 18 years or older.
- Confirmed diagnosis of primary non-small cell lung cancer with predominantly non-squamous pathology, locally advanced and unresectable (Stage III).
- Tumor has EGFR mutations Ex19Del, L858R, or combination including T790M, confirmed by specific mutation tests.
- Received concurrent or sequential chemoradiation with at least 2 cycles of platinum-based chemotherapy and radiation dose of 54 to 66 Gy.
- Completed chemoradiation within 6 weeks before randomization.
- No disease progression during or after chemoradiation.
- WHO performance status of 0-1 without deterioration over the past 2 weeks and life expectancy of at least 12 weeks.
- Females must use adequate contraception, not breastfeed, and have a pregnancy test before first dosing unless non-child-bearing.
- Males must agree to use barrier contraception.
You will not qualify if you...
- Prior chemotherapy, radiation, immunotherapy, or investigational treatment for NSCLC outside definitive Stage III treatment; prior EGFR-TKI therapy.
- Major surgery within 4 weeks before first dose, excluding vascular access placement.
- Use of medications or supplements affecting cytochrome CYP3A4 within 7 days before first dose.
- Treatment with investigational drugs within five half-lives of the compound.
- Mixed small cell and non-small cell lung cancer histology.
- History of interstitial lung disease before chemoradiation.
- Symptomatic pneumonitis after chemoradiation.
- Inadequate bone marrow or organ function.
- Unresolved toxicity Grade 2 or higher from prior chemoradiation.
- Abnormal heart conditions, including prolonged QTc, conduction issues, heart failure, or low left ventricular ejection fraction.
- History of other malignancies except fully treated non-melanoma skin cancer, in-situ cancer, or cancers without recurrence for over 5 years.
- Severe or uncontrolled systemic diseases or active infections like hepatitis B, C, or HIV.
- Severe nausea, vomiting, gastrointestinal disease preventing swallowing study drug.
- Hypersensitivity to Almonertinib or related drugs.
- Investigator judgment of inability to comply with study requirements.
- Severe uncontrolled eye disease posing safety risks.
- Any condition compromising patient safety or study assessments per investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Ji'nan, Shandong, China, 250117
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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