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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Guang Han — Hubei Cancer Hospital
• Study coordinator: Guang Han
• Email: hg7913@hotmail.com
• Phone: 13886048178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.