Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung… (NCT05601973) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI
France, Italy, Netherlands60 participantsStarted 2023-03-27
Plain-language summary
AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial.
In addition, the safety of the treatment combination will be evaluated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or stage IV according to 8th TNM classification.
✓. Presence of a sensitising EGFR-mutation (only patients with exon 19 deletion and/or L858R are eligible) and documentation of T790M status, tested locally by an accredited laboratory.
✓. Radiologically confirmed disease progression on previous treatment with osimertinib or lazertinib.Treatment with osimertinib must have been stopped at least 8 days before enrolment.
✓. Achieved objective clinical benefit from osimertinib or lazertinib treatment (e.g., documented PR/ CR or SD for ≥6 months while on osimertinib or lazertinib treatment).
✓. Measurable disease as defined according to RECIST v1.1.
✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
✓. Life expectancy ≥12 weeks.
Exclusion criteria
✕
What they're measuring
1
Efficacy of amivantamab and bevacizumab added to continued treatment with a third-generation EGFR-TKI (osimertinib or lazertinib)
Timeframe: from date of enrolment until 12 weeks of follow-up.
. Patients with known small cell lung carcinoma (SCLC) transformation.
✕. Patients with symptomatic brain metastases. Patients with asymptomatic or previously treated and stable brain metastases may participate in this study. Patients who have received definitive radiotherapy or surgery for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at ≥2 weeks before enrolment are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (≤10 mg/day prednisone or equivalent) for at least 2 weeks prior to enrolment.
✕. Patients with an active or past medical history of leptomeningeal disease.
✕. Patients with untreated spinal cord compression. Patients who have been definitively treated with surgery or radiotherapy and have a stable neurological status for ≥2 weeks prior to enrolment are eligible provided they are off corticosteroid treatment or are receiving low-dose corticosteroid treatment ≤10 mg/day prednisone or equivalent.
✕. Patients with unresolved adverse events (other than alopecia) from prior anticancer therapy that have not resolved to grade ≤1 or baseline.
✕. Patients with positive hepatitis B (hepatitis B virus \[HBV\]) surface antigen (HBsAg) test.
✕. Patients with positive hepatitis C antibody (anti-HCV) test.
✕. Patients with other clinically active infectious liver disease.