Actively Recruiting
A Phase II Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Uncommon EGFR Mutation (IcomBine, GASTO-10114)
Led by Sun Yat-sen University · Updated on 2024-07-25
23
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of two targeted drugs, Befotertinib and Icotinib, as a first-line treatment for people with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has uncommon EGFR mutations. This Phase II study aims to better understand how this drug combination works in patients who have not yet received systemic treatment for advanced NSCLC. The study focuses on specific rare EGFR mutations, including exon 18 G719X, S768I in exon 20, and L861Q in exon 21. Participants will receive oral doses of Icotinib 125 mg three times daily along with Befotertinib 100 mg once daily until their disease progresses or they meet criteria to stop treatment. The study does not include a placebo group and does not use blinding. Patients previously treated with EGFR-TKIs or systemic therapies for advanced NSCLC are not eligible. During the study, participants will be monitored for treatment response, including the objective response rate over 24 months, progression-free survival and disease control rate over 12 months, and overall survival at 24 months. Evaluations will include tumor measurements based on RECIST criteria, performance status assessments, and safety monitoring. The total duration and follow-up will vary based on individual patient progress and treatment response.
CONDITIONS
Brief Title
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Pathologically confirmed lung adenocarcinoma, locally advanced or metastatic (stage IIIB, IIIC, or IV), not suitable for curative surgery or radiotherapy
- Treatment-naive for systemic antitumor therapy for locally advanced or metastatic NSCLC
- Confirmed rare EGFR mutations (exon 18 G719X, exon 20 S768I, or exon 21 L861Q) by central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Predicted survival of 3 months or more
- At least one measurable tumor lesion without prior radiotherapy
- Agreement to use effective contraception during and for 3 months after study treatment
- Provision of informed consent before any study procedures
You will not qualify if you...
- Presence of other malignancies except clinically cured in situ cervix carcinoma, basal cell or squamous skin cancer, or thyroid papillary carcinoma
- Prior treatment with any EGFR-tyrosine kinase inhibitors (EGFR-TKIs)
- Prior systemic antitumor therapy for locally advanced or metastatic NSCLC
- Use of traditional Chinese medicine with antitumor effects within 2 weeks before study drug
- Major surgery within 4 weeks before study drug or planned major surgery during study
- Worsening symptoms or signs within 2 weeks before study drug
- Unresolved toxicities from prior treatments above grade 2
- Symptomatic or unstable central nervous system metastases requiring steroids; stable CNS allowed if stable for 4 weeks
- Serious or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding disorders, thrombus, cardiovascular or cerebrovascular diseases
- Active infections such as hepatitis B, hepatitis C, syphilis, or HIV
- Abnormal ECG or heart function (QTcF ≥ 450 msec or LVEF ≤ 50%)
- History of interstitial lung disease or related lung conditions
- Difficulty swallowing or oral malabsorption
- Laboratory abnormalities including low neutrophils, platelets, hemoglobin, elevated liver enzymes or bilirubin, or impaired kidney function
- Known allergy or hypersensitivity to study drugs or components
- Use of potent CYP inhibitors or inducers within 1 week before study drug
- Ongoing use of warfarin within 1 week before study drug
- Participation in other therapeutic clinical trials within 4 weeks before study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive orally administered Icotinib and Befotertinib together until disease progression or discontinuation criteria are met.
Regular visits as per protocol
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xue Hou, MD
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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