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Completed

NCT Number: NCT05688046

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

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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Key information

Conditions

NSCLC

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, 215001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • No concurrent malignancy.
  • Not participating in a clinical trial.
  • The functions of important organs were basically normal.
  • Sign informed consent.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. OS

    Time frame: 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

    Time frame: Up to August 1, 2022

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

  3. irAEs

    Time frame: Up to August 1, 2022

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

Sponsors and collaborators

Lead sponsor

Suzhou Municipal Hospital

Other

Registry information

Official study 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

Acronym: IMAGINE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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