Clinical Trial

A Global, Phase 3, Randomized, Multicenter, Open-label Study To
Evaluate The Efficacy And Safety Of Firmonertinib Compared With
Investigator’s Choice Of Osimertinib Or Afatinib As First-line Treatment In
Participants Who Have Locally Advanced Or Metastatic Non-small-cell
Lung Cancer With Epidermal Growth Factor Receptor P-loop And Alpha
C-helix Compressing (PACC) Uncommon Mutations (ALPACCA)

MOA: Firmonertinib is an oral EGFR inhibitor with activity against EGFR classical and uncommon mutations, and HER2 mutations.

Key Eligibility

• Cyto/histologically documented locally advanced or metastatic
  NSCLC not amenable to curative surgery or radiotherapy
• Measurable disease per RECIST v1.1 (non irradiated and preferably
  not used for biopsy)
• Documented EGFR PACC mutation in tumor tissue or blood from
  local testing via validated NGS or PCR assay
  • NOTE: PACC mutations may not be identified as “PACC” on NGS
    reports. Please see the protocol for specific included mutations.
• EGFR mutations like exon 19 del, L858R or C797S are excluded
• Archival tumor tissue must be provided (15 unstained slides)
• At least 12 months since completion of prior (neo)adjuvant or
  chemoradiation tx
  • Prior tx with EGFR-targeted agent is excluded
  • Prior systemic anti-cancer tx for advanced NSCLC is excluded