- Design
- Prospective, single-arm, multicentre phase 2 trial
- Population
- 61 adults with EGFR-mutant NSCLC after progression on a third-generation EGFR TKI
- Primary outcome
- Objective response rate at 12 weeks
- Effect
- 33% (95.6% CI 21–47); grade 3–4 treatment-related events 43%
AMAZE-lung, a single-arm phase 2 trial at 17 European sites, gave 61 patients with EGFR-mutant non-squamous NSCLC that had progressed on a third-generation EGFR inhibitor the combination of amivantamab, an EGFR-MET bispecific antibody, with lazertinib and bevacizumab.
The 12-week objective response rate was 33% in the first 60 patients, meeting the prespecified threshold, and 39% had a partial response at some point. Infusion reactions affected 58% and acneiform rash 50%. Venous thromboembolism occurred in 17%. Grade 3 or 4 treatment-related events affected 43%, with no treatment-related deaths.
Amivantamab with chemotherapy is already approved in some countries after osimertinib. This triplet avoids chemotherapy but has not been compared with it, and single-arm response rates are not survival. For pulmonologists who diagnose and often co-manage these patients, the toxicities to recognise are infusion reactions, skin toxicity and thrombosis.
- Rebiopsy or send circulating tumour DNA at progression on osimertinib to look for resistance mechanisms.
- Discuss thromboprophylaxis with the oncology team for patients on amivantamab-based regimens.
- Recognise infusion reactions and acneiform rash as expected toxicities, usually manageable.
- Investigate new breathlessness for pulmonary embolism and pneumonitis in patients on these regimens.
Why it matters
Patients may soon be offered a chemotherapy-free second line, with a distinct toxicity profile.
Don't overread it
Single-arm phase 2 data cannot establish benefit over standard treatment.
The statistics, in plain English
A response rate of 33% with an interval of 21% to 47% is promising for this setting, but without a control arm it cannot show longer survival than existing treatment.
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