Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT06032052

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

Led by Hubei Cancer Hospital · Updated on 2024-03-15

49

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 or older with performance status 0 to 2
  • Diagnosis of metastatic non-small cell lung cancer confirmed by histology or cytology
  • No mutations or fusions in common driving genes EGFR, ALK, or ROS1 (adenocarcinoma requires genetic testing)
  • Positive PD-L1 expression with tumor proportion score of 1% or higher
  • First-line treatment with stable brain or bone metastases or stable symptoms after local treatment
  • Available enhanced CT images of chest and supraclavicular area before treatment and measurable tumor lesions
  • Estimated survival time of at least 6 months
  • Laboratory results within 2 weeks before treatment showing hemoglobin ≥110 g/L, leukocytes ≥4x10^9/L, platelets ≥100x10^9/L, and liver/kidney function within 1.25 times upper normal limit
  • Informed consent signed and voluntary participation
Not Eligible

You will not qualify if you...

  • Presence of mutations or fusions in EGFR, ALK, or ROS1 genes
  • Previous systemic treatment for lung cancer
  • History of other malignant tumors except stage I non-melanotic skin cancer or cervical carcinoma in situ
  • Current involvement in other drug trials
  • Positive HIV infection receiving antiviral therapy
  • Active pulmonary tuberculosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

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Research Team

G

Guang Han

CONTACT

L

Lulu Shi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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