A clinical study exploring the effect of amivantamab and lazertinib plus bevacizumab treatment, in people diagnosed with advanced non-small cell lung cancer (NSCLC) that shows a change (mutation) in the EGFR gene and has spread to other parts of the body during or after treatment with osimertinib or lazertinib.
- Conditions
- patients with EGFR-mutant advanced NSCLC with progression on previous third generation EGFR TKITherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002337-42-IT
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1.Histologically confirmed non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or stage IV according to 8th TNM classification
2.Presence of the 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.
3.Radiologically confirmed disease progression on previous treatment with osimertinib or lazertinib.
Treatment with osimertinib or lazertinib must have been stopped at least 8 days before enrolment.
4.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).
5.Measurable disease as defined according to RECIST v1.1.
6.Age =18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.Patients with known small cell lung carcinoma (SCLC) transformation.
2.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.
3.Patients with an active or past medical history of leptomeningeal disease.
4.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 enrollment are eligible provided they are off corticosteroid treatment or are receiving low-dose corticosteroid treatment =10 mg/day prednisone or equivalent.
5.Patients with unresolved adverse events (other than alopecia) from prior anticancer therapy that have not resolved to grade =1 or baseline.
6.Patients with positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) test.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method