NCT05319886

Observational Study of the Efficacy and Safety of Anlotinib Combined With Penpulimab in Elderly Lung Cancer Patients

A Phase IV Observational Study Evaluating the Efficacy and Safety of Anlotinib in Combination With Penpulimab as First-line Treatment in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: —

Summary

This prospective observational study will evaluate the efficacy and safety of anlotinib in combination with Penpulimab in elderly patients with lung cancer. Data will be collected from each patient at baseline and after 4-6 cycles of therapy.

Detailed description

This research study is a Phase IV clinical trial. Participants are being involved in the portion of the study to observe the efficacy and safety of an observational intervention and also tries to evaluate the disease control rate (such as Progression-Free-Survival, overall survival, Objective Response Rate, Disease control rates, Duration of Response, Quality of Life and Adverse events). Anlotinib is a small molecule multi-target tyrosine kinase inhibitor, can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and tumor growth inhibiting effects. Penpulimab injection is a new PD-1 monoclonal antibody drug, was approved for marketing by the State Drug Administration (NMPA) of China for the indication: treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have undergone at least second-line systemic chemotherapy. By putting these two drugs together, the investigators hope that it will have a greater effect on cancer growth in elderly patients with lung cancer. Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (complete response (CR)+partial response (PR)+stable disease (SD)) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as disease progression (PD). Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD. The purpose of this study is to: * Test the efficacy of these two drugs Anlotinib and Penpulimab in elderly lung cancer; * Determine the Progression-Free-Survival of the combination; * Further evaluate the side effect profile for the combination of Anlotinib and Penpulimab in elderly lung cancer patients.

Conditions

• Lung Cancer
• Lung Carcinoma
• Non Small Cell Lung Cancer
• Non-small Cell Carcinoma
• Lung Neoplasm

Interventions

Type	Name	Description
DRUG	Anlotinib and Penpulimab	Anlotinib 12mg, po, qd, with 2 weeks off for 1 week. Penpulimab 200mg, ivgtt, q3w. Efficacy was evaluated every 2 cycles. Efficacy evaluation was performed every 2 cycles during the follow-up study. Patients with disease control (CR+PR+SD) and tolerable adverse reactions continued to take the drug until the investigator considered that the patient was not suitable to continue the drug or the efficacy was evaluated as PD. Safety evaluations were performed concurrently with the dosing period. No other antitumor therapy can be administered until PD.

Timeline

• Start date: 2022-05-16
• Primary completion: 2023-03-30
• Completion: 2025-03-30
• First posted: 2022-04-08
• Last updated: 2022-05-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study