A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 3
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
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 participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the Informed Consent Form (ICF).
- •Aged ≥ 18 years old. Participants from Japan/Taiwan aged ≥ 20 years old.
- •Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.
- •Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).
- •Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).
- •Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and/or classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.
排除标准
- •A participant would be excluded from the study if he/she meets any of the following:
- •NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.
- •Incomplete resection (R1/R2) or segmentectomy or wedge resection only.
- •Prior treatment with any of the following:
- •Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.
- •prior treatment with neoadjuvant therapy.
- •Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.
- •Previous ILD (including drug-induced ILD) or active ILD/active radiation pneumonitis.
研究组 & 干预措施
Firmonertinib
Firmonertinib: 240 mg, QD, orally
干预措施: Firmonertinib (Drug)
Placebo
Placebo: 240 mg, QD, orally
干预措施: Placebo (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: Up to 3 years
DFS as assessed by the investigator in Stage II- IIIB. DFS defined as the time from the date of randomization to the first observation of disease recurrence (by pathological diagnosis or imaging) or death caused by any reason, whichever occurs first.
次要结局
- Disease free survival rates(Up to 5 years)
- Adverse event (AE)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Overall survival rates(Up to 5 years)
- Disease free survival (DFS)(Up to 3 years)