Lung Cancer Squamous CellNCT06772454
To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Lung Cancer Squamous Cell and COPD, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Squamous Cell, COPD
- What is being tested?
- Antitumor therapy and Inhaled preparation for COPD
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 12 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years, diagnosed with stage IIIb-Ⅳ primary squamous non-small cell lung cancer, diagnosed as stable moderate to severe chronic obstructive pulmonary disease (COPD), genetic testing showed negative driver genes, ECOG PS 0-2 scores, and prior bronchodilators and inhaled corticosteroids were required to undergo a eluting period of at least 15 days. Patients volunteered to join the program.
Who may be able to join
- This project is a multi-center, randomized controlled, intentionality analysis study.
- Age ≥18 years old;
- Histological or cytological examination confirmed clinically primary squamous non-small cell lung cancer stage IIIB-IV (according to AJCC 8th Edition);
- Patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) were diagnosed according to the GOLD2021 standard and the Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021), with blood eosinophils ≤300 /ul and ≥100 /ul;
- The gene test showed that the driver gene (EGFR/ALK/BRAF/ROS1/KRAS/ HER2/MET/RET /NTRK) was negative;
- ECOG PS 0-2 points;
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- Clinical evaluation is suitable for suglizumab combined with paclitaxel (albumin-bound) and carboplatin anti-tumor first-line therapy, as well as chronic obstructive pulmonary maintenance therapy with long-acting bronchodilators or inhaled corticosteroids;
- Clinical records of suglizumab treatment, chemotherapy and other treatments are available;
- Patients who have previously used bronchodilators and inhaled corticosteroids should undergo a washout period of at least 15 days;
- Patients voluntarily join the project and sign informed consent;
Who cannot join
- 10. Concurrent with any malignant active tumor other than squamous non-small cell lung cancer; 11. Prior systematic treatment for advanced/metastatic non-small cell lung cancer; 12. Patients with diseases requiring long-term oral or intravenous use of glucocorticoids, such as autoimmune diseases, asthma, nephritis, type 1 diabetes, hyperthyroidism, etc.; Etc.; 13. Oral or intravenous use of glucocorticoids for any reason within 1 month prior to screening; 14. The patient was assessed by the researchers as having severe liver and kidney dysfunction; 15. Accompanied by acute type I/II respiratory failure or long-term use of non-invasive or invasive ventilator assisted ventilation or frequent acute exacerbations (≥2 times/year of moderate and severe acute exacerbations); 16. Women who are pregnant or nursing, or who are planning to become pregnant; Currently receiving or planning to participate in any other clinical studies;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
NO.28 Qiaozhong Zhong Road, Liwan District, Guangzhou City, Guangdong Province
Guangzhou, Guangdong, 510163
CHENGZHI ZHOU, +86-13560351186, doctorzcz@163.com
About this study
To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD)
- Conditions
- Lung Cancer Squamous Cell, COPD
- Being tested
- Antitumor therapy, Inhaled preparation for COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antitumor therapyDrug
All patients received suglizumab + paclitaxel + carboplatin:
Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles
Inhaled preparation for COPDDrug
60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group.
Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day.
Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Antitumor therapy | All patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles. Receives: Drug: Antitumor therapy | |
| Inhaled preparation for COPD | 60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily. Receives: Drug: Inhaled preparation for COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSF、Time and severity of the first acute exacerbation of severe COPD (AECOPD)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Squamous CellStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772454
- Sponsor's protocol ID
- CROC202315
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Inhaled Corticosteroids Combined With Bronchodilators and Programmed Death-ligand 1 (PD-L1) Inhibitor Plus Platinum-based Chemotherapy in Patients With Advanced Lung Squamous Cell Carcinoma Complicated With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT06772454
- Acronym / sponsor ID
- CROC202315
- Conditions
- Lung Cancer Squamous Cell, COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 13 Jan 2025 (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.
To evaluate the efficacy and safety of inhaled corticosteroids combined with bronchodilators and programmed death-ligand 1 (PD-L1) inhibitor plus platinum-based chemotherapy in patients with advanced lung squamous cell carcinoma complicated with chronic obstructive pulmonary disease (COPD)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antitumor therapy | – | Drug: Antitumor therapyAll patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles. |
| Inhaled preparation for COPD | – | Drug: Inhaled preparation for COPD60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years, diagnosed with stage IIIb-Ⅳ primary squamous non-small cell lung cancer, diagnosed as stable moderate to severe chronic obstructive pulmonary disease (COPD), genetic testing showed negative driver genes, ECOG PS 0-2 scores, and prior bronchodilators and inhaled corticosteroids were required to undergo a eluting period of at least 15 days. Patients volunteered to join the program.
Key inclusion criteria (10 listed)
- This project is a multi-center, randomized controlled, intentionality analysis study.
- Age ≥18 years old;
- Histological or cytological examination confirmed clinically primary squamous non-small cell lung cancer stage IIIB-IV (according to AJCC 8th Edition);
- Patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) were diagnosed according to the GOLD2021 standard and the Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised 2021), with blood eosinophils ≤300 /ul and ≥100 /ul;
- The gene test showed that the driver gene (EGFR/ALK/BRAF/ROS1/KRAS/ HER2/MET/RET /NTRK) was negative;
Key exclusion criteria (1 listed)
- 10. Concurrent with any malignant active tumor other than squamous non-small cell lung cancer; 11. Prior systematic treatment for advanced/metastatic non-small cell lung cancer; 12. Patients with diseases requiring long-term oral or intravenous use of glucocorticoids, such as autoimmune diseases, asthma, nephritis, type 1 diabetes, hyperthyroidism, etc.; Etc.; 13. Oral or intravenous use of glucocorticoids for any reason within 1 month prior to screening; 14. The patient was assessed by the researchers as having severe liver and kidney dysfunction; 15. Accompanied by acute type I/II respiratory failure or long-term use of non-invasive or invasive ventilator assisted ventilation or frequent acute exacerbations (≥2 times/year of moderate and severe acute exacerbations); 16. Women who are pregnant or nursing, or who are planning to become pregnant; Currently receiving or planning to participate in any other clinical studies;
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 |
|---|---|---|
| Antitumor therapyAll patients received suglizumab + paclitaxel + carboplatin: Suglizumab 1200 mg IV Q3W Paclitaxel (albumin-bound) 100 mg/m2 IV, D1, 8, 15, Q3W Carboplatin AUC=5 mg/mL/min IV Q3W A total of 4 administration cycles were given, and Suglizumab 1200 mg IV Q3W was maintained after 4 administration cycles | Drug | Antitumor therapy |
| Inhaled preparation for COPD60 patients were randomly assigned to the following two groups in a 1:1 ratio, with about 30 patients in each group. Group A: Receiving a long-acting beta-2 agonist (LABA) + a long-acting anticholinergic (LAMA) combination: Glonium bromide formoterol inhalation aerosol (7.2ug/5ug, trade name: Biwapin, Astrazeneca), 2 inhalations twice a day. Group B: Received inhaled glucocorticoid (ICS) +LABA+LAMA as a three-drug combination: budesonide/glononium bromide/formoterol :160ug/7.2ug/4.8ug, Astrazeneca), 2 inhalations twice daily. | Drug | Inhaled preparation for COPD |
Primary outcome
PSF、Time and severity of the first acute exacerbation of severe COPD (AECOPD)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Squamous Cell and COPD, run by Guangzhou Institute of Respiratory Disease 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 10 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHOU (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSF、Time and severity of the first acute exacerbation of severe COPD (AECOPD) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2025.