Pembrolizumab as First-line Treatment for Advanced NSCLC Complicated With COPD

NCT05578222 | Unknown Phase 2

• 1 other identifier: NSCLC+COPD-Pembrolizumab-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the efficacy and safety of pembrolizumab in the first-line treatment of advanced NSCLC complicated with COPD and its influence on the course of COPD, so as to provide prospective clinical evidence for immunotherapy of NSCLC complicated with COPD in China and to guide clinical application.

Conditions

NSCLC With COPD

Outcome Measures

Primary Outcomes (1)

• PFS

  The time from the beginning of randomization to the progression of tumor development or death for any reason.

  30 months

Secondary Outcomes (3)

• ORR

  12 months

• Rate of acute exacerbations of COPD (times/year)

  30 months

• adverse events

  30 months

Study Arms (1)

treatment group

EXPERIMENTAL

All patients who met the inclusion criteria and did not meet the exclusion criteria were enrolled in the treatment group

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab, 200mg i.v. gtt,D1,Q3W,

Also known as: Keytruda,NSCLC,COPD

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent before enrollment;
• Men and women aged 18-75;
• The patient must be able to provide fresh or archived tumor tissue and its pathology report;
• No previous antitumor therapy, life expectancy is not less than 12 weeks;
• Newly diagnosed NSCLC subjects confirmed by pathology and imaging; Stage: cT1-4N1-3M1 (stage Ⅳ), AJCC eighth edition clinical staging of lung cancer;
• Asymptomatic patients with NSCLC brain metastases
• PD-L1 tumor fraction (TPS) ≥1%;
• Epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative;
• Measurable lesions that meet RECIST v1.1 criteria;
• Patients with COPD who met the relevant diagnostic criteria for COPD in the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021) formulated by Chinese Society of Respiratory Medicine, and whose condition was stable for ≥2 weeks;
• ECOG PS: 0 \~ 2;
• The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) :
• Normal bone marrow reserve, neutrophil (ANC) ≥1,500/mm³, platelet count (PLT) ≥100,000/mm³, hemoglobin (Hb) ≥5.6 mmol/L (9g/dL);Creatinine (Cr) ≤1.5 mg/d and/or Clearance of creatinine (CCr) ≥60 ml/min;Normal liver function or Total Bilirubin (TBIL) ≤1.5 ULN,Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤1.5 ULN;
• Non-surgical sterilization or use of a medically approved contraceptive method (e.g. intrauterine device, birth control pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period;Patients with non-surgical sterilization or women of childbearing age had to have a negative serum or urine HCG test within 7 days before study enrollment; must be non-lactation period;Male patients who are not surgically sterilized or of childbearing age are required to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period;
• Subjects volunteered to join this study, with good compliance, safety and survival follow-up.

You may not qualify if:

• Previous radiotherapy, chemotherapy, long-term or high-dose hormone therapy, surgery, or molecular targeted therapy;
• The subject has previous or concurrent other malignant tumors;
• History of asthma or other respiratory diseases (bronchiectasis, tuberculosis, interstitial pneumonia, occupational lung disease, sarcoidosis, etc.);Patients with objective evidence of radiation pneumonitis, drug-associated pneumonitis, or severe impairment of pulmonary function;
• History of lobectomy;
• A history of clinically significant circulatory failure;
• Significant contraindications for spirometry (history of myocardial infarction, cerebral artery or aortic aneurysm, history of eye surgery, hemoptysis);
• Patients with rheumatic diseases;Patients with heart, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases.
• Patients with a history of acute gastrointestinal bleeding within 3 months;
• Previous immune checkpoint inhibitor therapy;The subject is known to have a previous allergy to macromolecular protein preparations, or to any PD-1 mab component;
• The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Subjects with vitiligo or complete remission of asthma in childhood without any intervention as adults were included;Subjects with asthma requiring medical intervention with bronchodilators were excluded);
• The subject has active infection or unexplained fever \>38.5 ℃ during the screening period or before the first administration;
• The subject is participating in another clinical study or it has been less than one month since the end of the previous clinical study;Subjects may receive other systemic antitumor therapy during the study;
• Receive live vaccine less than 4 weeks before or possibly during the study period;
• The subject cannot or does not agree to pay for the examination and treatment expenses at his own expense;
• Pregnant or lactating women;

Sponsors & Collaborators

• Tianjin Chest Hospital: lead

Study Sites (1)

Tianjin Chest Hospital

Tianjin, 300350, China

RECRUITING

Related Publications (1)

• Dong W, Yin Y, Liu B, Jiang Y, Wang L, Shi D, Qin J. Efficacy and safety of pembrolizumab as first-line treatment for advanced non-small cell lung cancer complicated with chronic obstructive pulmonary disease: protocol for a prospective, single-arm, single-center, phase II clinical trial. Front Oncol. 2024 Mar 7;14:1179232. doi: 10.3389/fonc.2024.1179232. eCollection 2024.

  PMID: 38515570 DERIVED

MeSH Terms

Interventions

pembrolizumab

Study Officials

• JianWen Qin

  No. 261, Taierzhuang South Road, Jinnan District, Tianjin, Tianjin Chest Hospital.

  STUDY DIRECTOR

Central Study Contacts

JianWen Qin

CONTACT

022-88185060; qinjianwen2005@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physicians

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 10, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

CN (1)