Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061219) titled 'A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer' on April 10.
Study Type:
Observational
Primary Sponsor:
Institute - Wakayama Medical University
Condition:
Condition - Non-small cell lung cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - The objective of this study is to evaluate the prognosis of patients with early-stage or locally advanced non-small cell lung cancer harboring KRAS G12C mutations who have received standard treatment.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Cohort 0
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Anatomical lung resection performed on or after June 1, 2025
4 Pathological complete resection
5 Clinical stage II, IIIA, N2 IIIB disease treated with neoadjuvant therapy including immune checkpoint inhibitors, followed by anatomical lung resection
6 Pathological complete response achieved
7 18 years or older
8 Written informed consent from patients
Cohort 1
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Anatomical lung resection performed on or after June 1, 2025
4 Pathological complete resection
5 Either of the following criteria
a, Patients who underwent surgery without neoadjuvant therapy and were diagnosed with pathological stage II, III disease, and who received (or are scheduled to receive) adjuvant therapy
b, Patients with clinical stage II, IIIA, N2 IIIB disease who received neoadjuvant therapy including immune checkpoint inhibitors followed by anatomical lung resection, regardless of postoperative immunotherapy, and who did not achieve pCR
6 18 years or older
7 Written informed consent from patients
Cohort 2
1 Histologically confirmed NSCLC
2 KRAS G12C mutation confirmed
3 Patients with clinical stage III disease who received definitive chemoradiotherapy on or after June 1, 2025, followed by initiation of durvalumab consolidation therapy or planned to receive
4 18 years or older
5 Written informed consent from patients
Key exclusion criteria - 1 Patients with synchronous malignancies requiring treatment at the time of enrollment
2 Patients who declined participation in the study
3 Patients enrolled in a clinical trial using off-label agents for completely resected stage II or III NSCLC or unresectable stage III NSCLC
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2035 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070050
Disclaimer: Curated by HT Syndication.
