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

NCT05688046 — Completed, 79 participants, Suzhou Municipal Hospital

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

Registry	NCT05688046, acronym IMAGINE
Status	Completed
Study type	Observational
Enrollment	79 (Actual)
Sponsor	Suzhou Municipal Hospital (Other)
Conditions	NSCLC
Interventions	Immune checkpoint inhibitors plus angiogenesis inhibitors, Immune checkpoint inhibitors without angiogenesis inhibitors (Drug)
Dates	start 2019-01-01, primary completion 2022-08-01, completion 2022-12-31, first posted 2023-01-18, last updated 2023-01-19
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
IA group		Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors	Immune checkpoint inhibitors plus angiogenesis inhibitors group
NIA group		Drug: Immune checkpoint inhibitors without angiogenesis inhibitors	Immune checkpoint inhibitors without angiogenesis inhibitors group

Immune checkpoint inhibitors plus angiogenesis inhibitors (Drug): PD-(L)1-based therapy plus Bevacizumab or Anlotinib
Immune checkpoint inhibitors without angiogenesis inhibitors (Drug): PD-(L)1-based therapy

+Outcome measures

Primary outcomes

PFS [Up to August 1, 2022]: PFS was defined as the time from the start of the first immunotherapy until disease progression or death

Secondary outcomes

OS [Up to August 1, 2022]: OS was defined as the time from the start of the first immunotherapy to death from any cause
ORR [Up to August 1, 2022]: ORR refers to the sum of complete response and partial response to treatment
irAEs [Up to August 1, 2022]: Immune-related adverse events were evaluated according to the CTCAE5.0 criteria

+Eligibility

Sex: All, ages: 65 Years to any

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.

+Locations (1)

Facility	City	Country	Status
The Affiliated Suzhou Hospital of Nanjing Medical University	Suzhou, Jiangsu	China

+Investigators

Jing Xue, Principal investigator, The Affiliated Suzhou Hospital of Nanjing Medical University