Phase 3, open-oabel, randomized study of amivantamab and lazertinib in combination with platinum-based chemotherapy compared with platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic Non- Small Cell Lung Cancer after osimertinib failure.
2e lijn na osimertinib
Patients with EGFR-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure.
Key outcome parameters
amivantamab, lazertinib, chemotherapy
Key inclusion criteria
- articipant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous NSCLC, characterized at or after the time of locally advanced metastatic disease diagnosis by either EGFR Exon 19del or Exon 21 L858R mutation
- Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR TKI.
- Participant must have at least 1 measurable lesion, according to RECIST v1.1
- A participant with definitively, locally treated brain metastases must be clinically stable and asymptomatic, with or without low-dose corticosteroid treatment (≤10 mg prednisone or equivalent), for at least 14 days prior to randomization.
- ECOG 0-1
Key exclusion criteria
- Participant received prior systemic anticancer therapy in the locally advanced or metastatic setting, or in the adjuvant setting, for the same nonsquamous NSCLC intended for treatment now
- Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
- Participant has active brain metastases not definitively treated with local therapy
- Participant has known small cell transformation
- Participant has uncontrolled tumor-related pain
- Participant has a medical history of ILD, including drug-induced ILD or radiation pneumonitis