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A new study for previously treated locally advanced or metastatic RAS[MUT] non-small cell lung cancer.

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated.

What you need to know

Who can take part?

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
  • Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  • Able to take oral medications.

Exclusion criteria

  • Prior therapy with direct RAS-targeted therapy or docetaxel.
  • Ongoing anticancer therapy.

What is involved for me?

  • Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
  • Your study doctor will also explain what you will have to do and the tests that you will have during the study. A brief overviews includes; blood tests, physical examination, vital signs, tumour Assessment (CT scan/MRI)/PET, Urine test, ECG, Questionnaire. 
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