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

Completed

• Conditions: NSCLC
• Interventions: Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors; Drug: Immune checkpoint inhibitors without angiogenesis inhibitors

• Registration Number: NCT05688046
• Lead Sponsor: Suzhou Municipal Hospital

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.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Last Update Submitted: 2023-01-17
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IA group	Immune checkpoint inhibitors plus angiogenesis inhibitors	Immune checkpoint inhibitors plus angiogenesis inhibitors group
NIA group	Immune checkpoint inhibitors without angiogenesis inhibitors	Immune checkpoint inhibitors without angiogenesis inhibitors group

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The Affiliated Suzhou Hospital of Nanjing Medical University; 🇨🇳 Suzhou, Jiangsu, China