Furmonertinib for Non-small Cell Lung Cancer

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

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Carcinoma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
318 (estimated)
Sponsor
Allist Pharmaceuticals, Inc. · Industry
Who this trial is looking for

This trial is looking for patients with a specific type of lung cancer who have had their tumors completely removed. Participants will receive either the medication Furmonertinib or a placebo to see how well it works and its safety.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with non-small cell lung cancer.
  • I have had complete removal of my lung tumor.
  • I have specific mutations in my tumor known to respond to EGFR drugs.
  • I have fully recovered from my surgery.
  • I have a performance status of 0 or 1.
  • I am not pregnant and am using effective birth control if I can become pregnant.

You may not be able to join if

  • I have received radiation therapy for my lung cancer.
  • I have had prior cancer treatments for this lung cancer.
  • I had major surgery within 4 weeks of the study.
  • I have severe or uncontrolled health issues.
  • I have a history of lung disease that needs treatment.
  • I have unexplained sudden death in my family under 40.
  • I have had certain heart rhythm problems.
  • I have taken certain medications that affect liver enzymes.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 c…
Trial Locations
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Eligibility Criteria
Inclusion 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 c…
Contacts

Jianxing He, PHD

020-83062114

drjianxing.he@gmail.com

CONTACT

Wenhua Liang, PHD

020-83062114

liangwh1987@163.com

CONTACT