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

Sponsor
Allist Pharmaceuticals, Inc.
Study ID
NCT04853342
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 7, 2021
Status verified
Mar 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2030

Study Design

Enrollment
318 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Furmonertinib
    Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.
  • Placebo Comparator: Placebo Furmonertinib
    Matching placebo for Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.

Primary Outcome Measure

DFS [ Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence). Estimated median time to event of 60 months for those treatment) [ Time Frame: Up to 5 years] ]

Central Contacts

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