A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer

A Registry Study of Early-Stage and Locally Advanced KRAS-Mutant Non-Small Cell Lung Cancer - REGORAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061219

Enrollment

400

Registered

2026-04-10

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
cohort 1:Disease free survival (DFS) cohort 2:Progression free survival (PFS)	—

Secondary

Measure	Time frame
Overall survival (OS) Patterns of recurrence or progression Post-recurrence treatment Frequency of KRAS gene mutations and their association with clinicopathological characteristics	—

Countries

Japan

Contacts

Public ContactTaichi Matsubara

Kyushu University Hospital Department of Thoracic Surgery

taichi.m0930@gmail.com092-642-5466

Outcome results