A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer
NCT07661173 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2026-06-22
Summary
Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC
Conditions
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
Firmonertinib
80mg QD
- DRUG
-
Firmonertinib/pemetrexed/Carboplatin
Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed maintenance every 3 weeks.
- DRUG
-
Firmonertinib/pemetrexed/Carboplatin/Bevacizumab
Drug: Firmonertinib daily and pemetrexed plus carboplatin on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by firmonertinib daily with pemetrexed and bevacizumab maintenance every 3 weeks.
Sponsors & Collaborators
-
Anhui Provincial Cancer Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-06
- Primary Completion
- 2029-03-06
- Completion
- 2031-05-06
Countries
- China
Study Locations
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