Clinical trial NCT05688046: Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: Elderly Patient
Lead sponsor: Suzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 79
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: Up to August 1, 2022
Secondary outcomes:
measure: OS
timeFrame: Up to August 1, 2022
measure: ORR
timeFrame: Up to August 1, 2022
measure: irAEs
timeFrame: Up to August 1, 2022
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Affiliated Suzhou Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Suzhou Hospital of Nanjing Medical University
name: Jing Xue
role: PRINCIPAL_INVESTIGATOR
References: