Single-drug chemotherapy combined with immunotherapy for elderly patients with metastatic lung cancer

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

This study is testing if combining a single-drug chemotherapy with immunotherapy can help older patients with advanced lung cancer live longer and feel better compared to just using traditional chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Hubei Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06032052 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of single-drug chemotherapy combined with immunotherapy in elderly patients aged 65 and older who have metastatic non-small cell lung cancer (NSCLC). The study aims to determine whether this treatment approach can improve progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy alone. The trial includes patients with confirmed metastatic NSCLC who express PD-L1 and have no common genetic mutations. By focusing on this unique age group, the study seeks to provide tailored treatment options for elderly lung cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 65 and older with metastatic NSCLC and positive PD-L1 expression.

Not a fit: Patients with common genetic mutations such as EGFR, ALK, or ROS-1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes for elderly patients with metastatic lung cancer.

How similar studies have performed: Previous studies have shown that immunotherapy combined with chemotherapy can improve survival outcomes in advanced NSCLC, suggesting a promising approach for this patient population.

Eligibility criteria

Inclusion Criteria:

1. Regardless of sex, age ≥ 65, PS 0-2.
2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.
3. 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).
4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).
5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).
6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.
7. The estimated survival time is not less than 6 months.
8. 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.
9. Informed understanding and voluntary participation in this study, and informed consent has been signed.

Exclusion Criteria:

1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).
2. Have received systemic treatment before.
3. 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.
4. Other drugs are being tested.
5. Patients with positive HIV and are receiving antiviral therapy .
6. Active pulmonary tuberculosis.

Where this trial is running

Wuhan, Hubei

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

Study contacts

• Principal investigator: Guang Han — Hubei Cancer Hospital
• Study coordinator: Guang Han

Conditions Elderly Patients; Metastatic Lung Cancer