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Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study

Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study - Explore research of chemoimmunotherapy and angiogenesis inhibitor for KRAS-mutant non-small cell lung cancer patients; prospective observation study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049780
Enrollment
30
Registered
2023-01-04
Start date
2022-12-01
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-squamous non-small cell lung cancer

Interventions

None listed

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Non-squamous cell non-small cell lung cancer confirmed by histology or cytology. (2) Clinical stage IIIB, IIIC, IVA, IVB* or postoperative recurrence for which surgery or curative radiation is not possible. *Lung Cancer Treatment Regulations (April 2021 [8th Edition, Revised]) Japan Lung Cancer Society/Ed. (2) Cases of recurrence after adjuvant therapy for the treatment of non-small cell lung cancer could be enrolled as long as it is the first treatment after the completion of adjuvant chemotherapy. (3) Patients must be at least 20 years of age at the time of consent. (4) Patients with KRAS active gene mutation (G12C, G12D/S, G12A/V/R, or G13C). (5) Patients who are scheduled to receive combination therapy with chemotherapy, angiogenesis inhibitors, or immune checkpoint inhibitors, including platinum-based agents, in accordance with the latest package insert and the latest guidelines for promoting optimal use of each drug. (6) Written consent has been obtained from the patients after a thorough explanation of the study details has been provided prior to enrollment in this clinical study.

Exclusion criteria

Exclusion criteria: (1) Patients deemed inappropriate by the physician in charge.

Design outcomes

Primary

MeasureTime frame
Progression free survival: PFS

Secondary

MeasureTime frame
Time to treatment failure: TTF Overall survival: OS Overall response rate; ORR Disease control rate; DCR Adverse events including immune related adverse events.

Countries

Japan

Contacts

Public ContactMasaki Ishida

University Hospital, Kyoto Prefectural University of Medicine Department of pulmonary medicine

mishida@koto.kpu-m.ac.jp075-251-5513

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026