To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.

Trial Details

NCT ID
NCT04853342
Phase
PHASE3
Sponsor
Allist Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Drug: Furmonertinib 80 mg
  • Furmonertinib 80 mg placebo
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • Male or female, aged at least 18 years.
  • Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
  • MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
  • Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria.

For full eligibility, visit ClinicalTrials.gov.

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