NSCLC With COPDPhase 2NCT05578222
Pembrolizumab as First-line Treatment for Advanced NSCLC Complicated With COPD
A Phase 2 study testing Pembrolizumab in people with NSCLC With COPD, run by Tianjin Chest Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC With COPD
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to 12 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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);
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- 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;
- Subjects with innate or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminases did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥10⁴/ml;HCV RNA≥10³/ml);Chronic hepatitis B virus carriers, HBV DNA≥2000 IU/ml (≥10⁴ copies/ml), must receive antiviral therapy during the trial to be enrolled;
- 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;
- Other conditions that should be excluded from the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Chest Hospital
Tianjin, 300350
JianWen Qin, 022-88185060, qinjianwen2005@aliyun.com
About this study
Official title: Efficacy and Safety of Pembrolizumab as First-line Treatment for Advanced Non-small Cell Lung Cancer Complicated With Chronic Obstructive Pulmonary Disease: a Prospective, Single-arm, Single-center Phase II Trial
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.
Read the detailed description
This clinical study mainly includes 3 stages of screening, treatment and follow-up.
Pabolivizumab at a fixed dose of 200 mg intravenous infusion on day 1 for Q3W, continued to maintain administration for no more than 35 cycles, or until the imaging proves the early termination of PD or other protocols. Imaging evaluation is performed every 6 weeks within 6 months from the first dose of pabolizumab and approximately every 12 weeks thereafter until disease progression or early withdrawal. Conduct regular safety assessments, document changes in COPD condition, track adverse events until remission or stabilization, or restore baseline levels, or receive other anti-tumor therapy; Record the combined medications.
Main research objectives:Evaluation of PFS in patients with advanced NSCLC and COPD treatment of pabolivizumab.
Secondary research objectives:To assess the ORR and acute exacerbation rate (times/person/year) and adverse reactions of PABLIZUMAB in patients with advanced NSCLC with COPD.
Purpose of exploratory research:The expression levels of PD-L1, CD4+ and CD8+ T lymphocytes in tumor tissues of patients with NSCLC and COPD before treatment were laboratory tested, and the correlation between different COPD grades and immune cell infiltration and efficacy was explored. This study was designed as a single-armed, single-center, prospective, phase II clinical study with 30 clinical, radiographic, pulmonary function and pathologically confirmed advanced (stage IV) NSCLC combined with COPD primary treatment subjects.
- Conditions
- NSCLC With COPD
- Being tested
- Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda,NSCLC,COPD
Pembrolizumab, 200mg i.v. gtt,D1,Q3W,
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | All patients who met the inclusion criteria and did not meet the exclusion criteria were enrolled in the treatment group Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the beginning of randomization to the progression of tumor development or death for any reason.
Measured: 30 months
Secondary outcomes (3)
ORR
The proportion of patients whose tumor volume has decreased to a prespecified value and can maintain a minimum time limit.ORR=PR+CR
Measured: 12 months
Rate of acute exacerbations of COPD (times/year)
Acute exacerbations of COPD are coughs, sputum production, worsening of dyspnea, or increased amount of sputum, or yellow phlegm, requiring a change in medication regimen.Acute exacerbations of COPD are classified as Grades I.-III according to clinical signs.
Measured: 30 months
adverse events
Harmful reactions that are not related to the purpose of medication under normal dosage of qualified drugs. Refer to CTCAE 5.0
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion12 Dec 2023 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC With COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianwen Qin, Tianjin Chest Hospital
- Investigators
- JianWen Qin, Study director, No. 261, Taierzhuang South Road, Jinnan District, Tianjin, Tianjin Chest Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578222
- Sponsor's protocol ID
- NSCLC+COPD-Pembrolizumab-001
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38515570
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pembrolizumab as First-line Treatment for Advanced Non-small Cell Lung Cancer Complicated With Chronic Obstructive Pulmonary Disease: a Prospective, Single-arm, Single-center Phase II Trial
- ClinicalTrials.gov ID
- NCT05578222
- Acronym / sponsor ID
- NSCLC+COPD-Pembrolizumab-001
- Conditions
- NSCLC With COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical study mainly includes 3 stages of screening, treatment and follow-up.
Pabolivizumab at a fixed dose of 200 mg intravenous infusion on day 1 for Q3W, continued to maintain administration for no more than 35 cycles, or until the imaging proves the early termination of PD or other protocols. Imaging evaluation is performed every 6 weeks within 6 months from the first dose of pabolizumab and approximately every 12 weeks thereafter until disease progression or early withdrawal. Conduct regular safety assessments, document changes in COPD condition, track adverse events until remission or stabilization, or restore baseline levels, or receive other anti-tumor therapy; Record the combined medications.
Main research objectives:Evaluation of PFS in patients with advanced NSCLC and COPD treatment of pabolivizumab.
Secondary research objectives:To assess the ORR and acute exacerbation rate (times/person/year) and adverse reactions of PABLIZUMAB in patients with advanced NSCLC with COPD.
Purpose of exploratory research:The expression levels of PD-L1, CD4+ and CD8+ T lymphocytes in tumor tissues of patients with NSCLC and COPD before treatment were laboratory tested, and the correlation between different COPD grades and immune cell infiltration and efficacy was explored. This study was designed as a single-armed, single-center, prospective, phase II clinical study with 30 clinical, radiographic, pulmonary function and pathologically confirmed advanced (stage IV) NSCLC combined with COPD primary treatment subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: PembrolizumabAll patients who met the inclusion criteria and did not meet the exclusion criteria were enrolled in the treatment group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: Keytruda,NSCLC,COPDPembrolizumab, 200mg i.v. gtt,D1,Q3W, | Drug | treatment group |
Primary outcome
PFS
Time frame: 30 months
The time from the beginning of randomization to the progression of tumor development or death for any reason.
3 secondary outcomes
ORR
Time frame: 12 months
Rate of acute exacerbations of COPD (times/year)
Time frame: 30 months
adverse events
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 38515570Dong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JianWen Qin study director
No. 261, Taierzhuang South Road, Jinnan District, Tianjin, Tianjin Chest Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with NSCLC With COPD, run by Tianjin Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JianWen Qin (022-88185060, qinjianwen2005@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.