Actively Recruiting
A Multicenter, Randomized, Controlled, Double Blind, Double Simulated Phase III Study of Befotertinib vs Icotinib as Postoperative Adjuvant Treatment for Stage IB-IIIB Non-Small Cell Lung Cancer with EGFR Sensitive Mutations
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2023-09-22
570
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Befotertinib compared with Icotinib as postoperative adjuvant treatments in adults with stage IB-IIIB non-small cell lung cancer that has EGFR-sensitive mutations. This Phase III, multicenter, randomized, controlled, double-blind study focuses on patients whose cancer has been surgically removed and aims to improve disease-free survival. The study is sponsored by Betta Pharmaceuticals Co., Ltd. and targets patients with specific EGFR mutations linked to treatment sensitivity. Participants are randomly assigned to receive either Befotertinib plus an Icotinib placebo or Icotinib plus a Befotertinib placebo. Befotertinib is taken orally once daily starting at 75 mg and increasing to 100 mg if tolerated, for up to three years or until disease recurrence or unacceptable side effects. Icotinib or its placebo is taken orally three times daily for up to two years under similar conditions. The double-simulated design ensures all participants take both a study drug and a placebo. Throughout the study, participants will attend scheduled visits for monitoring, including laboratory tests and safety assessments. Researchers will measure disease-free survival up to five years after treatment starts, focusing on cancer recurrence or progression. The study includes careful tracking of side effects and overall health, with follow-up extending to evaluate outcomes over a prolonged period. Participants must meet specific health and recovery criteria following surgery to join and remain in the trial.
CONDITIONS
Brief Title
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and able to follow study visits and procedures
- Male or female aged 18 years or older
- Histologically confirmed primary non-small cell lung cancer, mainly non-squamous type
- No brain metastasis
- Complete surgical removal of stage IB, II, IIIA, or IIIB (T3N2M0) lung cancer with negative margins
- Tumor confirmed to have EGFR-sensitive mutations Ex19del or L858R
- Fully recovered from surgery with complete wound healing
- Adjuvant treatment planned within 4 to 10 weeks after surgery
- ECOG performance status 0 or 1 with expected survival over 12 weeks
- Negative pregnancy test for females with fertility need
- Use of effective contraception during study and for 3 months after treatment if able to become pregnant
You will not qualify if you...
- Presence of unresectable or metastatic disease, positive surgical margins, or remaining lesions after surgery
- Only wedge resection performed
- Upper lung groove cancer
- Complete resection of right lung with NSCLC
- Other malignancies within 5 years except certain treated cancers
- Prior systemic anti-tumor therapy before enrollment
- Major surgery within 3 weeks before first study drug dose
- Use of anti-tumor traditional Chinese medicine within 14 days before first dose
- Need for additional anti-tumor treatments after study start
- Significant cardiovascular diseases or ECG abnormalities
- History or presence of interstitial lung disease or drug-induced lung toxicity
- History or risk of thrombosis
- Serious active infections or diseases affecting drug acceptance
- Significant gastrointestinal problems affecting drug absorption
- Abnormal laboratory test results
- Known allergy to study drugs or their ingredients
- Use of strong CYP3A inhibitors or inducers near study start
- Use of warfarin within 7 days before initial dosing
- Participation in other clinical trials within 4 weeks or planned during this study
- Live vaccine within 180 days before first drug dose
- Conditions affecting protocol compliance or informed consent, including mental illness or addiction
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 - Up to 3 years or until disease relapse or intolerable toxicity
Participants receive either Befotertinib or Icotinib as postoperative adjuvant treatment to help prevent cancer recurrence.
Regular visits scheduled during treatment period as per protocol
Trial Site Locations
Total: 3 locations
1
Peking University International Hospital
Beijing, China
Actively Recruiting
2
Jiangsu Cancer Hospital
Nanjing, China
Actively Recruiting
3
Shanghai chest hospital
Shanghai, China
Actively Recruiting
Research Team
S
Shun Lu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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