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

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

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215001
      • The Affiliated Suzhou Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Suzhou Municipal Hospital
• Investigators: Principal Investigator: jing xue, The Affiliated Suzhou Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Elderly Patient
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immune Checkpoint Inhibitors; Angiogenesis Inhibitors
• Other Study ID Numbers: IMAGINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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