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.
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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
RECRUITINGProgression Free Survival
The time from the start of treatment until objective tumor progression or death. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.
Time frame: 2 years
Overall Survival
Overall survival is the time elapsed between enrollment and death of any cause. For participants who don't die until the end of treatment, the overall survival data will be analyzed retrospectively based on their date of death after the end of study.
Time frame: 2 years
Objective Response Rate
This refers to the percentage of patients with a certain amount of tumor shrinkage that is maintained for a certain period of time, including CR and PR.
Time frame: 2 years
Disease control rates
Includes the number of cases of CR, PR, and SD with confirmed disease as a percentage of patients evaluable for efficacy.
Time frame: 2 years
Duration of Response
Time between the start of the first evaluation of the tumor as CR or PR and the first evaluation of PD or death from any cause
Time frame: 2 years
Adverse events
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Time frame: 2 years