Elderly PatientsPhase 2NCT06032052
Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
A Phase 2 study testing Single drug chemotherapy plus immunotherapy in people with Elderly Patients and Metastatic Lung Cancer, run by Hubei Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Metastatic Lung Cancer
- What is being tested?
- Single drug chemotherapy plus immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lulu Shi contact
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Han Guang, MD
Han Guang, MD
About this study
Official title: Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
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.
Read the detailed description
Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The age range in which lung cancer is most commonly diagnosed is 65-74 years old. 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. The investigators pay special attention to elderly patients because they are a unique group.
With regard to the definition of "elderly", considering that more than half of cancer patients are aged 65 or above. Therefore, we set the definition of the elderly in this phase II clinical study to 65 years and older.
The results of Keynote-042 study, Keynote-189 study and Keynote-407 study all showed that 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. Meta analysis showed that in patients with advanced NSCLC, immunotherapy prolonged OS and PFS compared with chemotherapy, and the prolongation of PFS was not related to age, while OS also benefited in patients aged 65 to 75 years. To sum up, elderly patients benefit from immunotherapy.
It is controversial whether elderly advanced 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 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, in order to reduce the adverse reactions without reducing the curative effect and improve their quality of life.
- Conditions
- Elderly Patients, Metastatic Lung Cancer
- Being tested
- Single drug chemotherapy plus immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single drug chemotherapy plus immunotherapyDrug
Also called monochemotherapy plus immunotherapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Single drug chemotherapy plus immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: up to 12 months
Objective response rate
Measured: up to 6 months
Secondary outcomes (2)
Overall survival
Measured: up to 18 months
Disease control rate
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAN GUANG, Hubei Cancer Hospital
- Investigators
- Guang Han, Principal investigator, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032052
- Sponsor's protocol ID
- Unicorn
- Status last verified
- Mar 2024
- First submitted
- 22 Aug 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients
- ClinicalTrials.gov ID
- NCT06032052
- Acronym / sponsor ID
- Unicorn
- Conditions
- Elderly Patients, Metastatic Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The age range in which lung cancer is most commonly diagnosed is 65-74 years old. 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. The investigators pay special attention to elderly patients because they are a unique group.
With regard to the definition of "elderly", considering that more than half of cancer patients are aged 65 or above. Therefore, we set the definition of the elderly in this phase II clinical study to 65 years and older.
The results of Keynote-042 study, Keynote-189 study and Keynote-407 study all showed that 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. Meta analysis showed that in patients with advanced NSCLC, immunotherapy prolonged OS and PFS compared with chemotherapy, and the prolongation of PFS was not related to age, while OS also benefited in patients aged 65 to 75 years. To sum up, elderly patients benefit from immunotherapy.
It is controversial whether elderly advanced 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 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, in order to reduce the adverse reactions without reducing the curative effect and improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic NSCLC patients over 65 years old | Experimental | Drug: Single drug chemotherapy plus immunotherapyIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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%).
Key exclusion criteria (6 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single drug chemotherapy plus immunotherapyAlso: monochemotherapy plus immunotherapyThe 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 | Drug | Metastatic NSCLC patients over 65 years old |
Primary outcome
Progression-free Survival
Time frame: up to 12 months
Objective response rate
Time frame: up to 6 months
2 secondary outcomes
Overall survival
Time frame: up to 18 months
Disease control rate
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lulu Shi contact
Guang Han principal investigator
Hubei Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single drug chemotherapy plus immunotherapy in people with Elderly Patients and Metastatic Lung Cancer, run by Hubei Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang Han (13886048178, hg7913@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.