A Phase 3, Open-Label, 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.

Studiedetails

Type carcinoma: NSCLC met mutatie
Stadium: IIIB-IV
Mutatie: EGFR
Lijn: 2de lijns na osimertinib
Site: Erasmus MC
Contactgegevens:

long.oncologie@erasmusmc.nl

Website:

 Inclusiecriteria

  • Participant 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

 Exclusiecriteria

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

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