61186372NSC3002 – MARIPOSA-2
OC Oncoclínicas NOB
Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared to Platinum-Based Chemotherapy in Research Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Mutation After Failure of osimertinib
Critérios de inclusão
Participants must have histologically or cytologically confirmed non-squamous, locally advanced or metastatic NSCLC characterized at the time of or after diagnosis of L858R metastatic disease with exon 19 or exon 21 deletion;
Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as first-line treatment for locally advanced or metastatic disease, or as second-line treatment after prior treatment with a first- or second-generation EGFR TKI;
The participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated;
A participant with definitively locally treated brain metastases must be clinically stable and asymptomatic, with or without treatment with low-dose corticosteroids (prednisone 10 mg or equivalent), for at least 14 days prior to randomization.
Critérios de exclusão
The participant received radiotherapy for palliative treatment of NSCLC less than 14 days before randomization;
Participant with symptomatic or progressive brain metastases;
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis.