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

NSCLC Clinical Trial

— IMAGINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688046
• Other study ID #: IMAGINE
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Suzhou Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Suzhou Hospital of Nanjing Medical University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Municipal Hospital

Country where clinical trial is conducted

China, 

Outcome

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