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

Recruiting now · Phase 2

Conditions studied: Elderly Patients, Metastatic Lung Cancer

In brief

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.

Key facts

Study ID

NCT06032052

Run by

Hubei Cancer Hospital

People needed

49

Starts

2024-02-01

Expected to finish

2027-09-01

Last updated by the study team

2024-03-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Regardless of sex, age ≥ 65, PS 0-2.
• metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.
• No mutation or fusion of common driving genes, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).
• (adenocarcinoma requires genetic testing).
• Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).
• First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).
• Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.
• The estimated survival time is not less than 6 months.
• The clinical laboratory criteria within 2 weeks before treatment are as follows: hemoglobin ≥ 110g / L, leukocytes ≥ 4x109 / L, platelet ≥ 100x109 / L, liver and kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit of the normal value.
• Informed understanding and voluntary participation in this study, and informed consent has been signed.

You may not qualify if…

• Mutation or fusion of common driving genes (EGFR,ALK or ROS1).
• Have received systemic treatment before.
• Previous suffering from other malignant tumors (except stage I non-melanotic skin cancer or cervical carcinoma in situ) or other malignant tumors at the same time.
• Other drugs are being tested.
• Patients with positive HIV and are receiving antiviral therapy .
• Active pulmonary tuberculosis.

Where it is running

• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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