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

Elderly Patients Clinical Trial

Official title: Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The age range in which lung cancer is most commonly diagnosed is 65-74 years old. 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. The investigators pay special attention to elderly patients because they are a unique group.

With regard to the definition of "elderly", considering that more than half of cancer patients are aged 65 or above. Therefore, we set the definition of the elderly in this phase II clinical study to 65 years and older.

The results of Keynote-042 study, Keynote-189 study and Keynote-407 study all showed that 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. Meta analysis showed that in patients with advanced NSCLC, immunotherapy prolonged OS and PFS compared with chemotherapy, and the prolongation of PFS was not related to age, while OS also benefited in patients aged 65 to 75 years. To sum up, elderly patients benefit from immunotherapy.

It is controversial whether elderly advanced 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 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, in order to reduce the adverse reactions without reducing the curative effect and improve their quality of life. ;

Related Conditions & MeSH terms

• Elderly Patients
• Lung Neoplasms
• Metastatic Lung Cancer

• NCT number: NCT06032052
• Study type: Interventional
• Source: Hubei Cancer Hospital
• Contact: Guang Han
• Phone: 13886048178
• Email: hg7913@hotmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Completion date: September 2027