The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer (RAISE)

A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment

This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Osimertinib

Detailed Description

This is a multicenter, real-world, retrospective observational study designed to investigate the genomic landscape of recurrence in patients with early-stage (clinical stage IB-IIIA) non-small cell lung cancer harboring EGFR-sensitizing mutations who received adjuvant osimertinib. A total of 60 patients with resectable EGFR-sensitizing mutation-positive NSCLC (exon 19 deletion or exon 21 L858R) are expected to be included and classified into two cohorts. Cohort 1 consists of 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib, and Cohort 2 consists of 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed.

The primary endpoint is to evaluate the genomic landscape of recurrence during or after adjuvant osimertinib treatment in patients with resectable NSCLC harboring EGFR-sensitizing mutations. The secondary endpoints are to explore the genomic profiles of recurrence in subgroups with different recurrence patterns (local recurrence versus distant metastasis) during or after adjuvant osimertinib treatment, and to describe the treatment patterns used in real-world clinical practice after disease progression. The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression.

• Study Type: Observational
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yongchang Zhang, MD; Phone Number: 13873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Liang Zeng, MD; Phone Number: 15974139200

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Provincal Tumor Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: 13873123436 13873123436; Email: zhangyongchang@csu.edu.cn
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Yang Xia, MD; Phone Number: 18868439669 18868439669; Email: yxia@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This multicenter, retrospective, real-world study includes patients with resected stage IB-IIIA NSCLC harboring EGFR-sensitizing mutations (exon 19 deletion or exon 21 L858R) who received adjuvant osimertinib. A total of 60 patients are enrolled and classified into two cohorts based on recurrence timing: Cohort 1 comprises 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib; Cohort 2 comprises 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. All data are extracted from electronic medical records.

Description

Inclusion Criteria:

1. Informed consent signed;
2. Age ≥ 18 years;
3. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
4. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
5. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
6. Recurrence after/on Osimertinib treatment according to RECIST 1.1;
7. NGS gene test report (tumor or blood sample) at the time of recurrence;
8. Receiving or not receiving neoadjuvant treatment before surgery.

Exclusion Criteria:

1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
2. Received adjuvant therapy other than that specified in the ADAURA study;
3. No NGS test report at recurrence;
4. History of other malignant tumors within 2 years;
5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib.
Cohort 2; consists of 30 patients with recurrence during adjuvant osimertinib treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence gene profiles	To assess the recurrence gene profiles of adjuvant Osimertinib therapy	From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence gene profiles in patients with different recurrence types (local /distant)	To explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy	From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records
Subsequent treatment patterns	To describe the diverse treatment patterns (Osi or other EGFR TKIs，± chemo) in real clinical practice after the disease progressed	From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the mechanisms driving tumor progression	The exploratory endpoints are to investigate changes in the genomic profile between baseline and recurrence and to explore the mechanisms underlying tumor progression	From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: EGFR; Osimertinib
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: 2024-IIT0612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No