Evaluating befotertinib for advanced non-small cell lung cancer with specific EGFR mutations
Official title: Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06863506 · Data updated 2026-11-12
This study is testing a new drug called befotertinib to see if it can help people with advanced lung cancer who have specific types of EGFR mutations after other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, befotertinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06863506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with advanced or metastatic NSCLC harboring specific EGFR mutations and who have not previously received EGFR-TKI therapy.
✕Probably not a fit
Patients with active CNS metastases, severe cardiovascular disease, or those who have previously received EGFR-TKI treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II clinical trial investigates the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that have non-classical EGFR mutations. The trial consists of two cohorts: one for patients with uncommon EGFR mutations (G719X, L861Q, or S768I) and another for those with EGFR exon 20 insertion mutations. The primary endpoint is the objective response rate, while secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety profile. Participants must have progressed on or been intolerant to prior platinum-based chemotherapy.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with specific EGFR mutations in NSCLC who currently have limited treatment choices.
How similar studies have gone: Other studies have shown promising results with similar approaches targeting EGFR mutations, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years, ECOG performance status 0-2 * Histologically confirmed locally advanced/metastatic NSCLC * Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion) * No prior EGFR-TKI therapy * Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1 Exclusion Criteria: * Previous EGFR-TKI treatment * Active CNS metastases (asymptomatic patients with stable lesions allowed) * Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months) * Active HBV/HCV/HIV infection * Pregnancy or lactation
Where it's running
-
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Li Wen, Prof. — Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study coordinator: Xia Yang
- Email: yxia@zju.edu.cn
- Phone: +86 18868439669
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Investigating KQB365 for treating advanced solid tumors
This study tests if a new treatment called KQB365, alone or with another drug, can help adults with advanced solid tumors that have specific genetic mutations.
-
TS-104: a first-in-human, dose-escalation study for advanced solid tumors
This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.
-
Befotertinib with Rifampicin or Itraconazole in Healthy People
This study tests how Befotertinib behaves in the body when taken with rifampicin or itraconazole in healthy volunteers.
-
Icotinib after surgery for early EGFR-mutant NSCLC
This study tests whether giving icotinib after surgery helps patients with early-stage EGFR-mutant NSCLC compare to just following them after surgery.
-
Oral Paclitaxel with Immunotherapy and SBRT as Neoadjuvant Treatment for Older Adults with NSCLC
This trial tests a new, lighter neoadjuvant therapy that combines an oral paclitaxel solution, an immune checkpoint inhibitor, and SBRT for adults aged 70 and older with resectable NSCLC to see if it can shrink tumors before surgery.
-
Targeted Induction Therapy for Stage III Unresectable EGFR Mutant NSCLC
This trial tests a targeted induction approach using fumetinib with platinum-based chemotherapy and concurrent radiochemotherapy in adults with unresectable stage III EGFR-mutant NSCLC to see if this combo can improve outcomes before possible surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.