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Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study

Exploratory research of immunochemotherapy for advanced non-small cell lung cancer patients; prospective observation study - Prospective resaerch of immunochemotherapy for advanced NSCLC patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000043958
Enrollment
100
Registered
2021-04-19
Start date
2019-11-01
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

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients aged 20 years or older with PS0-2 at the time of consent (2) Patients with advanced or recurrent non-small cell lung cancer that is not curatively resectable (3) Patients with evaluable lesions by RECIST (version 1.1) (4) Patients who are scheduled to receive combination therapy with immune checkpoint inhibitors and chemotherapy (5) Patients whose tumor PD-L1 protein expression has been examined using formalin-fixed paraffin-embedded blocks in areas that do not interfere with pathological diagnosis, and whose consent has been obtained from the patient. (6) Patients who have been fully informed about the contents of this clinical study and have given free written consent from the research subject.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of treatment with systemic chemotherapy or immune checkpoint inhibitors (However, molecularly targeted cancer drugs for patients with driver gene mutation positive, and postoperative adjuvant chemotherapy for patients with postoperative recurrence are acceptable) (2)Other patients who are deemed inappropriate by the physician in charge.

Design outcomes

Primary

MeasureTime frame
Progression-free survival

Secondary

MeasureTime frame
Overall survival, response rate, disease control rate, time to treatment failure, and incidence and grade of adverse events including immune-related adverse events Association of PD-L1 expression in tumors with response to combined chemoimmunotherapy Association between treatment response and patient background for combined chemoimmunotherapy

Countries

Japan

Contacts

Public ContactYuki Katayama

Kyoto Prefectural University of Medicine Pulmonary Medicine

ktym2487@koto.kpu-m.ac.jp0752515513

Outcome results

None listed

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