NCT05601973Active, not recruitingPhase 2
ETOP 18-21 AMAZE-lung: 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.
ETOP 18-21 AMAZE-lung: A multicentre single-arm phase II trial of amivantamab, lazertinib plus bevacizumab in patients with EGFR-mutant advanced NSCLC with progression on previous third-generation EGFR-TKI.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Mar 2026
Brief summary (registry, in English)
The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with a third-generation EGFR-TKI (osimertinib or 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 first.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 4 Sept 2024
- Start date
- 11 Apr 2023
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Diseases
- Lung cancer
- NCT number
- NCT05601973
- EU CT number
- 2024-512288-29-00
- EudraCT number
- 2021-002337-42
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 11 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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 or hepatitis C antibody. • Patients with other clinically active infectious liver disease. • Patients who are positive for HIV. • Patients with active cardiovascular disease. • Patients with interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. • Patients with a history of haemoptysis (≥2.5 mL of bright red blood per episode) within 1 month prior to enrolment. • Patients with evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation). • Patients with current or recent (within 10 days before enrolment) use of aspirin (>325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and clostazol. • Patients with current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2 weeks prior to enrolment. • Patients with serious, non-healing wound, active ulcer, or untreated bone fracture. • Patients who had a core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrolment. • Patients who had major surgery or significant traumatic injury within 28 days prior to enrolment. • Patients who had placement of a vascular access device within 2 days prior to prior to enrolment. • Patients with a history of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to enrolment. • Patients with clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding. • Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure. • Patients with concurrent or prior malignancy other than the disease under study. • Patients with uncontrolled illness. • History of hypersensitivity to either the drug substance or any excipients in amivantamab, lazertinib and/ or bevacizumab. • Prior chemotherapy. • Prior treatment with bevacizumab or another anti-angiogenic inhibitor. • Prior treatment with a MET/EGFR-targeting antibody. • Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. • Women who are pregnant or in the period of lactation.
Who the study is looking for
- Histologically confirmed, non-squamous NSCLC, stage IIIB/C (not suitable for radical therapy) or stage IV according to TNM classification (8th edition). • Presence of a sensitizing EGFR mutation (only patients with exon 19 deletion and/or L858R mutation are eligible) and documented T790M status, tested on site by an accredited laboratory. • Radiologically confirmed disease progression during prior treatment with osimertinib or lazertinib. Treatment with osimertinib must have been stopped at least 8 days prior to study enrollment. • Achievement of objective clinical benefit from treatment with osimertinib or lazertinib (e.g. documented partial response (PR) or complete response (CR) or stable disease (SD) for ≥6 months under treatment with osimertinib or lazertinib). • Measurable disease as defined by RECIST v1.1. • Age ≥18 years • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. • Life expectancy of ≥ 12 weeks • Adequate hematologic, renal and liver function. • Written patient information and informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Completed |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
Related publications
- Combined amivantamab, lazertinib, and bevacizumab in patients with EGFR-mutant advanced non-small-cell lung cancer with acquired resistance to a third-generation EGFR tyrosine-kinase inhibitor (ETOP 18-21 AMAZE-lung): a prospective, international, multicentre, single-arm, phase 2 trial.Lancet Respir Med · 2026 · PMID 42833236
This page is information, not medical advice. Discuss any trial with your doctor.