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

NCT05688046 | Completed

• 1 other identifier: IMAGINE
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

Elderly Patient

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS was defined as the time from the start of the first immunotherapy until disease progression or death

  Up to August 1, 2022

Secondary Outcomes (3)

• OS

  Up to August 1, 2022

• ORR

  Up to August 1, 2022

• irAEs

  Up to August 1, 2022

Study Arms (2)

IA group

Immune checkpoint inhibitors plus angiogenesis inhibitors group

Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors

NIA group

Immune checkpoint inhibitors without angiogenesis inhibitors group

Drug: Immune checkpoint inhibitors without angiogenesis inhibitors

Interventions

Immune checkpoint inhibitors plus angiogenesis inhibitors DRUG

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

IA group

Immune checkpoint inhibitors without angiogenesis inhibitors DRUG

PD-(L)1-based therapy

NIA group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead

Study Sites (1)

The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, 215001, China

Location

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Angiogenesis Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors

Study Officials

• Jing Xue

  The Affiliated Suzhou Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: January 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: December 31, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)