MedTrace Logo

Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients

NCT06032052 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-03-15

No results posted yet for this study

Summary

Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The proportion of elderly lung cancer patients in the global lung cancer population is steadily increasing, at the same time, it is also the age group with the highest lung cancer mortality, but there is little evidence for treatment of elderly lung cancer patients. In this study, the investigators set the definition of the elderly to 65 years and older.

The progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy were higher than those of chemotherapy alone, which established the dominant position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly patients benefit from immunotherapy.

It is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can not significantly prolong OS, and can not improve the overall health status of patients. Based on the results of this study, single drug chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era of immunotherapy, it is not clear whether single-drug chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.

Conditions

  • Elderly Patients
  • Metastatic Lung Cancer

Interventions

DRUG

Single drug chemotherapy plus immunotherapy

The choice of chemotherapy plus immunotherapy for squamous cell carcinoma is gemcitabine or paclitaxel or vinorelbine. Paclitaxel or pemetrexed are available for monotherapy for non-squamous and non-small cell lung cancer. Immunotherapy drugs can be Pembrolizumab /Penpulimab/ Camrelizumab/ Tislelizumab / Sintilimab/ sulgarizumab and so on

Sponsors & Collaborators

  • Hubei Cancer Hospital

    lead OTHER

Principal Investigators

  • Guang Han · Hubei Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032052 on ClinicalTrials.gov