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

NCT06032052 | Recruiting Phase 2

• 1 other identifier: Unicorn
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Elderly Patients; Metastatic Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  up to 12 months

• Objective response rate

  up to 6 months

Secondary Outcomes (2)

• Overall survival

  up to 18 months

• Disease control rate

  up to 6 months

Study Arms (1)

Metastatic NSCLC patients over 65 years old

EXPERIMENTAL

In metastatic NSCLC patients over 65 years old, we employed gemcitabine or paclitaxel or vinorelbine plus immunotherapy for squamous cell carcinoma. Paclitaxel or pemetrexed plus immunotherapy are available for non-squamous and non-small cell lung cancer.

Drug: Single drug chemotherapy plus immunotherapy

Interventions

Single drug chemotherapy plus immunotherapy DRUG

The choice of chemotherapy plus immunotherapy for squamous cell carcinoma is gemcitabine or paclitaxel or vinorelbine. Paclitaxel or pemetrexed are available for monotherapy for non-squamous and non-small cell lung cancer. Immunotherapy drugs can be Pembrolizumab /Penpulimab/ Camrelizumab/ Tislelizumab / Sintilimab/ sulgarizumab and so on

Also known as: monochemotherapy plus immunotherapy

Metastatic NSCLC patients over 65 years old

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Guang Han

  Hubei Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Han

CONTACT

13886048178; hg7913@hotmail.com

Lulu Shi

CONTACT

027-87670318

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 11, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)