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

Sponsor
Suzhou Municipal Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05688046
Collaborator
(none)
79
1
48
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors
  • Drug: Immune checkpoint inhibitors without angiogenesis inhibitors

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

Study Type:
Observational
Actual Enrollment :
79 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
IA group

Immune checkpoint inhibitors plus angiogenesis inhibitors group

Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors
PD-(L)1-based therapy plus Bevacizumab or Anlotinib

NIA group

Immune checkpoint inhibitors without angiogenesis inhibitors group

Drug: Immune checkpoint inhibitors without angiogenesis inhibitors
PD-(L)1-based therapy

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. OS [Up to August 1, 2022]

    OS was defined as the time from the start of the first immunotherapy to death from any cause

  2. ORR [Up to August 1, 2022]

    ORR refers to the sum of complete response and partial response to treatment

  3. irAEs [Up to August 1, 2022]

    Immune-related adverse events were evaluated according to the CTCAE5.0 criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou Jiangsu China 215001

Sponsors and Collaborators

  • Suzhou Municipal Hospital

Investigators

  • Principal Investigator: Jing Xue, The Affiliated Suzhou Hospital of Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
jing xue, Associate chief physician, Suzhou Municipal Hospital
ClinicalTrials.gov Identifier:
NCT05688046
Other Study ID Numbers:
  • IMAGINE
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by jing xue, Associate chief physician, Suzhou Municipal Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2023