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Regimen-dependent impact of sex and smoking history on overall survival in advanced non-small cell lung cancer

Regimen-dependent impact of sex and smoking history on overall survival in advanced non-small cell lung cancer - Regimen-dependent impact of sex and smoking history on overall survival in advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000056267
Enrollment
Unknown
Registered
2024-11-25
Start date
2024-11-25
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

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients This study will include patients with advanced non-small cell lung cancer (NSCLC), encompassing metastatic, relapsed, and locally advanced diseases. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and non-squamous cancers are considered eligible. Studies exclusively targeting large cell neuroendocrine carcinoma (LCNEC) will be excluded. Treatment The experimental regimens must contain immune checkpoint inhibitors (ICIs), including PD-1 inhibitors, PD-L1 inhibitors, or CTLA-4 inhibitors. LAG-3 inhibitors will be excluded as no phase III trials are available at the time of the search. The analysis will include ICI monotherapy, dual ICI combinations, and ICIs combined with cytotoxic therapies. Both first-line and subsequent lines of therapy will be eligible. The control regimens must consist of cytotoxic therapies, placebo, or best supportive care. Molecular targeted therapies and ICIs must not be included in the control regimen. Based on the treatment regimens, studies will be categorized into three groups: (1) platinum-doublet chemotherapy plus one PD-(L)1 inhibitor, (2) ICI monotherapy, and (3) regimens containing CTLA-4 inhibitors. Study design and reporting style This study will include phase III trials (or phase II/III trials) published as full research article.

Exclusion criteria

Exclusion criteria: Studies exclusively targeting large cell neuroendocrine carcinoma (LCNEC) will be excluded. Chemoradiotherapy and perioperative treatments, including adjuvant or neoadjuvant therapy, will be excluded. Abstracts and non-English publications will be excluded. Studies that do not provide hazard ratios (HRs) for subgroups based on sex and smoking history will also be excluded.

Design outcomes

Primary

MeasureTime frame
rate of hazard ratio (RHR) of OS

Countries

Japan

Contacts

Public ContactNobuyuki Horita

Yokohama City University Hospital Chemotherapy Center

horitano@yokohama-cu.ac.jp045-787-2800

Outcome results

None listed

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