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

NCT05319886 | Unknown FDA Drug

• 1 other identifier: LC202103001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anlotinib; Penpulimab

Outcome Measures

Primary Outcomes (1)

• Progression 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.

  2 years

Secondary Outcomes (5)

• Overall Survival

  2 years

• Objective Response Rate

  2 years

• Disease control rates

  2 years

• Duration of Response

  2 years

• Adverse events

  2 years

Study Arms (1)

Anlotinib and Penpulimab

Drug: Anlotinib and Penpulimab

Interventions

Anlotinib and Penpulimab DRUG

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.

Also known as: AL3818 and AK105

Anlotinib and Penpulimab

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

At least 65 years old with locally advanced, recurrent or metastatic stage IIIB-IV non-small cell lung cancer.

You may qualify if:

• 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);
• Alaninetransaminase (ALT) ≤ 1.5 x ULN (ALT and AST ≤ 5 x ULN if liver metastases are present);
• Alkaline phosphatase (ALP) ≤ 1.5 x ULN;
• Albumin (ALB) ≥ 30g/L;
• Creatinine ≤1.5 x ULN or Creatinine Clearance (CCr) ≥ 60 ml/min;
• International normalized ratio (INR) ≤ 1.5 x ULN;

You may not qualify if:

• 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;
• Patients who had antineoplastic therapy against other malignancies, including radiotherapy, chemotherapy, immunotherapy and herbal medicine (except previously eradicated malignancies without recurrent metastases for ≥ 5 years);
• Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage (except patients who do not require drainage of effusion or whose effusion does not increase significantly after 3 days of cessation of drainage);
• Patients who have used immunosuppressive drugs within 4 weeks prior to the study treatment, except for topical glucocorticoids by nasal spray, inhalation or other routes or physiologic doses of systemic glucocorticoids (no more than 10 mg/day of prednisone or equivalent doses of other glucocorticoids);
• Patients who have known or suspected active autoimmune disease (congenital or acquired), such as interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (Patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled; Patients with type I diabetes with good insulin control may be enrolled);
• Patients who have known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453100, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib; penpulimab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Yinghua Ji, Master

CONTACT

13663030446; 54234317@qq.com

Yana Zhang, Doctor

CONTACT

15093230340; Drzhangyana@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: May 16, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2025
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

CN (1)