A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy(FIRMOST)

Recruiting Phase 3 Interventional Study
NSCLC Adjuvant Treatment
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.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
338 (estimated)
Sponsor
Allist Pharmaceuticals, Inc. · Industry
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About This Trial
This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy. About 338 eligible …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Sign the Informed Consent Form (ICF). 2. Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old. 3. Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology. 4. Underwent complete surgical resect…
Contacts

Li Zhang, Master

020-87342288

Zhangli6@mall.sysu.edu.cn

CONTACT