A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly.

A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly. - NLCTG2401

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060603

Enrollment

200

Registered

2026-02-07

Start date

2025-03-31

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

extensive stage of small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: From August 22, 2019 to April 30, 2024, patients who meet eligibility criterion (1) or (2) below and do not meet any of the exclusion criteria will be included. Eligibility criteria: (1) Patients with extensive-stage small-cell lung cancer diagnosed as small-cell lung cancer by histology or cytology, or patients with combined-type lung cancer who were treated as having extensive-stage small-cell lung cancer. (2) Patients diagnosed with extensive-stage small-cell lung cancer who did not receive systemic chemotherapy and were managed with best supportive care alone.

Exclusion criteria

Exclusion criteria: (1) Patients with limited-stage small-cell lung cancer who underwent surgery, definitive radiotherapy, or chemotherapy. (2) Patients enrolled in interventional studies (those enrolled only in observational studies are eligible).

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Comparison of overall survival between PD-L1 inhibitor plus platinum-based chemotherapy and platinum-based chemotherapy alone in patients aged 75 years or older with extensive-stage small-cell lung cancer.	—

Secondary

Measure	Time frame
Secondary endpoints: Progression-free survival, overall survival, safety (incidence of adverse events and treatment-related deaths), objective response rate, number of maintenance PD-L1 inhibitor administrations, duration of treatment success, association between immune-related adverse events (irAEs) and treatment efficacy, and association between concomitant use of proton pump inhibitors (PPIs), potassium-competitive acid blockers (P-CABs), antibiotics, probiotics, or antihistamines and treatment efficacy.	—

Measure

Time frame

Secondary endpoints: Progression-free survival, overall survival, safety (incidence of adverse events and treatment-related deaths), objective response rate, number of maintenance PD-L1 inhibitor administrations, duration of treatment success, association between immune-related adverse events (irAEs) and treatment efficacy, and association between concomitant use of proton pump inhibitors (PPIs), potassium-competitive acid blockers (P-CABs), antibiotics, probiotics, or antihistamines and treatment efficacy.

—

Countries

Japan

Contacts

Public ContactMinoru Kobayashi

Niigata University Graduate School of Medical and Dental Sciences Department of Respiratory Medicine and Infectious Diseases

kobami733.45hh@niigata-u.ac.jp08012361399

Outcome results