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)
Overview
- Phase
- Not Applicable
- Intervention
- Anlotinib and Penpulimab
- Conditions
- Lung Cancer
- Sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 65 years old;
- •Non-small cell lung cancer with locally advanced, recurrent or metastasis, which confirmed by histologically or cytologically (except sputum cytology) and evaluated as IIIB-IV stage, who are unresectable or unable to undergo radical radiotherapy or refuse radical radiotherapy. (If multiple tumor components are mixed, it should be classified according to their predominant cell type);
- •Participants are required to have one measurable disease per RECIST 1.1;
- •Unsuitable or unwilling to receive radical treatment methods (such as radical chemoradiotherapy and/or surgery) and have not received prior systemic therapy;
- •ECOG performance status of 0 to 2; The expected survival is more than 3 months;
- •Adequate organ and marrow function defined as follows:
- •Hemoglobin (HB) ≥90 g/L (no blood transfusion within 28 days);
- •Absolute neutrophil count (ANC) ≥1.5×109/L;
- •Platelet count (PLT) ≥ 100×109/L;
- •Aspartate Transaminase (AST) ≤ 1.5 x upper limit of normal (ULN);
Exclusion Criteria
- •Participants who have active infection;
- •Patients with known immunodeficiency diseases (e.g. psoriasis, active arthritis, immune nephropathy, HIV, etc);
- •Participants with no measurable disease;
- •Patients with cancerous meningitis and spinal cord compression;
- •Participants with active central nervous system (CNS) metastases (clinically stable and maintained for at least 2 weeks after adequate treatment of CNS metastases and do not require treatment such as glucocorticoids and dehydrating drugs are eligible for enrollment);
- •Previously treated with chemotherapy drugs (except neoadjuvant therapy) / targeted drugs / immunotherapy;
- •Participants who were confirmed severe abnormalities of gastrointestinal function (e.g. inability to take oral medications, uncontrollable nausea or vomiting, history of major gastrointestinal resection, untreated recurrent diarrhea, untreated gastric disease requiring long-term acid-suppressing PPI-like medications, Crohn's disease, ulcerative colitis);
- •Patients with central squamous lung cancer on imaging;
- •Patients who had an arterial/venous thrombotic event within 6 months, such as cerebrovascular accident (temporary ischemic attack is excluded), deep vein thrombosis and pulmonary embolism;
- •Patients whose imaging shows that the tumor has invaded a significant vessel or have a high risk of fatal hemorrhage due to tumor invasion of a significant vessel during the follow-up study judged by the investigator; or who have bleeding tendencies (e.g., active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogs;
Arms & Interventions
Anlotinib and Penpulimab
Intervention: Anlotinib and Penpulimab
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 2 years
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.
Secondary Outcomes
- Overall Survival(2 years)
- Objective Response Rate(2 years)
- Disease control rates(2 years)
- Duration of Response(2 years)
- Adverse events(2 years)