Actively Recruiting
Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations
Led by Avistone Biotechnology Co., Ltd. · Updated on 2026-03-20
40
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
CONDITIONS
Official Title
Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent signing
- Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer
- Confirmed presence of EGFR atypical mutation
- No prior systemic therapy for locally advanced or metastatic NSCLC
- At least one measurable lesion as defined by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function confirmed within 7 days before first dose of study treatment
- Female participants must use effective contraception during participation and for 90 days after last dose and must not be breastfeeding; females not of childbearing potential must be postmenopausal or surgically sterilized
- Non-sterilized males must use abstinence or contraception and not donate sperm
- Willing and able to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Presence of genetic alterations with approved targeted therapies available
- Participation in another interventional clinical trial within 28 days prior to study entry
- Major surgery within 28 days before study entry or planned during study period
- Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy
- Need for specific concomitant medications that cannot be paused during the study
- History of another active malignancy within past 5 years, except certain cured cancers
- Unrecovered toxicities from prior therapies
- Symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression
- Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites)
- Severe cardiovascular or cerebrovascular disease or risk factors
- History or presence of interstitial lung disease or drug/radiation-related pneumonitis
- Active autoimmune or inflammatory diseases
- Active uncontrolled infections including HBV, HCV, HIV, syphilis, tuberculosis
- Gastrointestinal disorders or surgery affecting drug absorption
- Active keratitis or ulcerative keratitis
- History of hypersensitivity to study drug, its analogs, or chemotherapy drugs used
- Live attenuated vaccine administration within 30 days prior
- Psychiatric disorders or substance abuse affecting compliance
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
H
Haimeng Li
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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