OncoMatch/Clinical Trials/NCT06032052
Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
Is NCT06032052 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Single drug chemotherapy plus immunotherapy for elderly patients.
Treatment: Single drug chemotherapy plus immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
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)
Required: ALK wild-type
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)
Required: ROS1 wild-type
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)
Required: PD-L1 (CD274) positive expression (TPS ≥ 1%) (TPS ≥ 1%)
Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%)
Disease stage
Required: Stage IV (AJCC 8th edition)
Metastatic disease required
metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
PS 0-2
Prior therapy
Cannot have received: systemic treatment
Have received systemic treatment before
Lab requirements
Blood counts
hemoglobin ≥ 110g / L, leukocytes ≥ 4x10^9 / L, platelet ≥ 100x10^9 / L
Kidney function
urea nitrogen, creatinine within 1.25 times of the upper limit of the normal value
Liver function
liver function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase) within 1.25 times of the upper limit of the normal value
hemoglobin ≥ 110g / L, leukocytes ≥ 4x10^9 / L, platelet ≥ 100x10^9 / 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
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