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Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients

Efficacy and Safety Analysis of Immune Checkpoint Inhibitors Plus Angiogenesis Inhibitors for Treatment of Advanced Driver-negative NSCLC in Elderly Patients:A Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05688046
Acronym
IMAGINE
Enrollment
79
Registered
2023-01-18
Start date
2019-01-01
Completion date
2022-12-31
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

Elderly Patient

Brief 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. 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.

Interventions

DRUGImmune checkpoint inhibitors plus angiogenesis inhibitors

PD-(L)1-based therapy plus Bevacizumab or Anlotinib

DRUGImmune checkpoint inhibitors without angiogenesis inhibitors

PD-(L)1-based therapy

Sponsors

Suzhou Municipal Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥65 years old. 2. Stage IV according to the AJCC Cancer grading manual (8th edition). 3. Histologically confirmed NSCLC. 4. No driver mutations. 5. Received at least 2 courses of immunotherapy. 6. Expected survival time \> 3 months. 7. No concurrent malignancy. 8. Not participating in a clinical trial. 9. The functions of important organs were basically normal. 10. Sign informed consent.

Design outcomes

Primary

MeasureTime frameDescription
PFSUp to August 1, 2022PFS was defined as the time from the start of the first immunotherapy until disease progression or death

Secondary

MeasureTime frameDescription
OSUp to August 1, 2022OS was defined as the time from the start of the first immunotherapy to death from any cause
ORRUp to August 1, 2022ORR refers to the sum of complete response and partial response to treatment
irAEsUp to August 1, 2022Immune-related adverse events were evaluated according to the CTCAE5.0 criteria

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026