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A retrospective observational study to examine the clinical background and course of treatment-effective cases of immune checkpoint inhibitor with or without cytotoxic anticancer therapy as initial chemotherapy in advanced non-small cell lung cancer

A retrospective observational study to examine the clinical background and course of treatment-effective cases of immune checkpoint inhibitor with or without cytotoxic anticancer therapy as initial chemotherapy in advanced non-small cell lung cancer - OLCSG2302

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051395
Enrollment
300
Registered
2023-08-01
Start date
2023-08-01
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

advanced non-small cell lung cancer

Interventions

None listed

Sponsors

National Hospital Organization Shikoku Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically (excluding sputum cytology) confirmed to be NSCLC. (Mixed types are excluded if they contain small cell carcinoma.) (ii) Patients have clinical stage III or IV (according to UICC-TNM 8th edition) or postoperative recurrent NSCLC for which radical resection or radical radiotherapy is not possible without systemic chemotherapy. (iii) ICI with or without chemo as indicated below is initiated as initial systemic chemotherapy from January 2019 to October 2021. However, if systemic chemotherapy (excluding cases treated with ICI) is given as postoperative chemotherapy, the patient is eligible if more than 6 months have elapsed since the last administration of that chemotherapy. (iv) The patient has been confirmed to be non-PD for at least 3 months after the start of ICI+chemo treatment.

Exclusion criteria

Exclusion criteria: (1) Patients have multiple cancers with a disease-free interval of less than 1 year at the time of ICI with or without chemo treatment. (Disease-free intervals are acceptable if the epithelial and intramucosal cancer lesions are judged to be curable by local treatment. (2) History of ICI treatment prior to initiation of ICI with or without chemo treatment. (iii) Recurrence after radical thoracic radiotherapy.

Design outcomes

Primary

MeasureTime frame
Efficacy and safety of initial immune checkpoint inhibitor with or without cytotoxic chemotherapy

Countries

Japan

Contacts

Public ContactTakashi Ninomiya

National Hospital Organization Shikoku Cancer Center Department of Thoracic Oncology and Medicine

harada.daijiro.kn@mail.hosp.go.jp+81-89-9991111

Outcome results

None listed

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