NSCLCIMAGINENCT05688046
Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients
An observational study of NSCLC, run by Suzhou Municipal Hospital at 1 site in China.
Trial summary
Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Immune checkpoint inhibitors plus angiogenesis inhibitors and Immune checkpoint inhibitors without angiogenesis inhibitors
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.A total of 43 patients in the NIA group and 36 patients in the IA group were included in the study between January 1,2019 and December 31,2021.
Who may be able to join
- Age ≥65 years old.
- Stage IV according to the AJCC Cancer grading manual (8th edition).
- Histologically confirmed NSCLC.
- No driver mutations.
- Received at least 2 courses of immunotherapy.
- Expected survival time > 3 months.
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- No concurrent malignancy.
- Not participating in a clinical trial.
- The functions of important organs were basically normal.
- Sign informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Suzhou Hospital of Nanjing Medical University
Suzhou, Jiangsu, 215001
About this study
Official title: Efficacy and Safety Analysis of Immune Checkpoint Inhibitors Plus Angiogenesis Inhibitors for Treatment of Advanced Driver-negative NSCLC in Elderly Patients：A Retrospective Study
Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.
Read the detailed description
The investigators reviewed the medical records of all lung cancer patients in the Cancer Diagnosis and Treatment Center of Suzhou Hospital Affiliated to Nanjing Medical University from January 1, 2019 to December 31, 2021, and a total of 79 patients were enrolled. The subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(IA group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(NIA group). The data of PFS, OS, ORR, covariates, and Immune-related adverse events (irAEs) were collected through electronic medical records and follow-up. The primary endpoint of the study was PFS, and the secondary endpoints were OS, ORR and irAEs.All enrolled patients were followed up until August 1, 2022.
- Conditions
- NSCLC
- Being tested
- Immune checkpoint inhibitors plus angiogenesis inhibitors, Immune checkpoint inhibitors without angiogenesis inhibitors
- Keywords
- Elderly Patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitors plus angiogenesis inhibitorsDrug
PD-(L)1-based therapy plus Bevacizumab or Anlotinib
Immune checkpoint inhibitors without angiogenesis inhibitorsDrug
PD-(L)1-based therapy
| Study group | Role | What they receive |
|---|---|---|
| IA group | Immune checkpoint inhibitors plus angiogenesis inhibitors group Receives: Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors | |
| NIA group | Immune checkpoint inhibitors without angiogenesis inhibitors group Receives: Drug: Immune checkpoint inhibitors without angiogenesis inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the time from the start of the first immunotherapy until disease progression or death
Measured: Up to August 1, 2022
Secondary outcomes (3)
OS
OS was defined as the time from the start of the first immunotherapy to death from any cause
Measured: Up to August 1, 2022
ORR
ORR refers to the sum of complete response and partial response to treatment
Measured: Up to August 1, 2022
irAEs
Immune-related adverse events were evaluated according to the CTCAE5.0 criteria
Measured: Up to August 1, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2019
- Primary completion1 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jing xue, Suzhou Municipal Hospital
- Investigators
- Jing Xue, Principal investigator, The Affiliated Suzhou Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688046
- Sponsor's protocol ID
- IMAGINE
- Acronym
- IMAGINE
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Analysis of Immune Checkpoint Inhibitors Plus Angiogenesis Inhibitors for Treatment of Advanced Driver-negative NSCLC in Elderly Patients：A Retrospective Study
- ClinicalTrials.gov ID
- NCT05688046
- Acronym / sponsor ID
- IMAGINE / IMAGINE
- Conditions
- NSCLC
- Keywords
- Elderly Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Suzhou Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Jan 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.
Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.
Detailed description
The investigators reviewed the medical records of all lung cancer patients in the Cancer Diagnosis and Treatment Center of Suzhou Hospital Affiliated to Nanjing Medical University from January 1, 2019 to December 31, 2021, and a total of 79 patients were enrolled. The subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(IA group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(NIA group). The data of PFS, OS, ORR, covariates, and Immune-related adverse events (irAEs) were collected through electronic medical records and follow-up. The primary endpoint of the study was PFS, and the secondary endpoints were OS, ORR and irAEs.All enrolled patients were followed up until August 1, 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IA group | – | Drug: Immune checkpoint inhibitors plus angiogenesis inhibitorsImmune checkpoint inhibitors plus angiogenesis inhibitors group |
| NIA group | – | Drug: Immune checkpoint inhibitors without angiogenesis inhibitorsImmune checkpoint inhibitors without angiogenesis inhibitors group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.A total of 43 patients in the NIA group and 36 patients in the IA group were included in the study between January 1,2019 and December 31,2021.
Key inclusion criteria (10 listed)
- Age ≥65 years old.
- Stage IV according to the AJCC Cancer grading manual (8th edition).
- Histologically confirmed NSCLC.
- No driver mutations.
- Received at least 2 courses of immunotherapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Immune checkpoint inhibitors plus angiogenesis inhibitorsPD-(L)1-based therapy plus Bevacizumab or Anlotinib | Drug | IA group |
| Immune checkpoint inhibitors without angiogenesis inhibitorsPD-(L)1-based therapy | Drug | NIA group |
Primary outcome
PFS
Time frame: Up to August 1, 2022
PFS was defined as the time from the start of the first immunotherapy until disease progression or death
3 secondary outcomes
OS
Time frame: Up to August 1, 2022
ORR
Time frame: Up to August 1, 2022
irAEs
Time frame: Up to August 1, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jing Xue principal investigator
The Affiliated Suzhou Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Suzhou Municipal 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 0 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: finished, as of the sponsor's last update on 19 Jan 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to August 1, 2022). 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 19 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.