A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 8
- 主要终点
- Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies
研究概览
简要总结
A study to create control arms using current and future information in patients with lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •> 18 years of age at the time of informed consent
- •Pathologically confirmed locally advanced or metastatic NSCLC
- •ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.
- •Life expectancy of more than 3 months
- •Able to understand and sign informed consent
- •Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)
- •*see protocol for cohort specific inclusion criteria*
排除标准
- •Actively on a clinical trial of an investigational agent
- •Currently receiving active systemic therapy for another malignancy
- •Eligible for treatment with curative intent
- •*see protocol for cohort specific exclusion criteria*
研究组 & 干预措施
Cohort 3
Patients with KRAS G12D mutations (excluding KRAS G12C) starting any line of therapy
Cohort 5
Patients with PD-L1 (TPS) < 50% starting second line therapy, after previously being treated with a platinum doublet in combination with ICI as first line treatment
Cohort 6
Patients without actionable tumor alterations in EGFR, ALK, or ROS 1 where PD-L1 status (TPS) is unknown, starting 2L therapy according to physician's choice
Cohort 4
Patients with PD-L1 (TPS) greater than or equal to 50% starting second line therapy, after previously being treated with single/doublet ICI or ICI in combination with a platinum doublet as first line treatment.
Cohort 8
Patients with non-G12 KRAS mutations starting 2L therapy
Cohort 9
Patients with EGFR mutations starting second line or later line of therapy, after previously being treated with osimertinib monotherapy, osimertinib in combination with chemotherapy or lazertinib in combination with amivantamab
Cohort 7
Patients with KRAS G12C mutation starting second line therapy
Cohort 1
Patients starting first line therapy with ICI single/doublet or ICI in combination with a platinum doublet
Cohort 2
Patients with actionable EGFR mutations starting first line therapy
Cohort 10
Patients starting 3 line or later line anti-cancer therapy (and not eligible for any other cohort)
Cohort 11
Patients with EGFR exon 19del or EGFR exon 21 L858R locally advanced or metastatic NSCLC diagnosed on Jan 1st, 2024, or later, irrespective of line of therapy or current treatment.
结局指标
主要结局
Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies
时间窗: September 2025-April 2029
次要结局
- Assess Progression Free Survival (PFS), Overall Survival (OS), and Time to Next Treatment (TTNT) by cohort in patients with metastatic NSCLC initiating second or third line treatment with NCCN recommended therapies.(September 2025-April2029)