Combining afatinib and bevacizumab for specific lung cancer mutations
Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer
This study is testing if combining two drugs, afatinib and bevacizumab, can help people with certain types of advanced lung cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Qingdao Central Hospital Academic / other |
| Drugs / interventions | Bevacizumab, afatinib, radiation |
| Locations | 2 sites (Qingdao, Shandong and 1 other locations) |
| Trial ID | NCT05267288 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of afatinib combined with bevacizumab in treating patients with metastatic non-small cell lung cancer (NSCLC) that have specific EGFR mutations (G719X, S768I, and L861Q). The trial aims to assess both the efficacy and safety of this combination therapy through various evaluations, including disease progression and patient-reported outcomes. Participants will undergo genetic characterization of their tumors and regular monitoring of their health status throughout the study.
Who should consider this trial
Good fit: Ideal candidates are patients with confirmed metastatic non-squamous NSCLC harboring EGFR mutations G719X, S768I, or L861Q.
Not a fit: Patients without the specified EGFR mutations or those with other types of lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with specific EGFR mutations in metastatic NSCLC.
How similar studies have performed: While this specific combination has not been previously reported, similar approaches targeting EGFR mutations in lung cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon G719X, S768I, L861Q mutation Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2 Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis Participant has a contraindication to the use afatinib or Bevacizumab
Where this trial is running
Qingdao, Shandong and 1 other locations
- Qingdao Central Hospital — Qingdao, Shandong, China (Recruiting)
- Qingdao Central Hospital — Qingdao, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.