Lung NeoplasmsCHAMPIONNCT04313361
A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery
An observational study of Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Johnson & Johnson (China) Investment Ltd. at 3 sites in China.
Trial summary
The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
- How many people
- 290 participants
- Where
- 3 sitesChina
- Study dates
- 6 May 2020to 9 Dec 2021
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult participant with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion, or other pulmonary conditions with a scheduled lung surgery and their treating health care providers (HCPs) from three participating hospitals in China.
Who may be able to join
- Participants who have been scheduled for an elective lung surgery by the treating physician's judgement, due to the following conditions: known lung cancer, COPD, a pulmonary lesion (example. nodule, ground glass opacity) or other pulmonary conditions
- Smokers who are or were smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years within 3 months prior to the scheduled surgery, or recent smoking quitters with a history of smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years, who quit smoking between 3 months and 5 years prior to the scheduled surgery
- Being willing to participate the study and sign the participant informed consent form (ICF)
Who cannot join
- Participants who have emergency lung surgery due to accident or injury
- Participants are not likely to be able to complete the 6-month follow-up after the lung surgery
Trial locations and contacts
3 sites in 1 country.
China3 sites
Xuanwu Hospital ,Capital Medical University
Beijing, 100053
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200000
About this study
Official title: China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)
The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the smoking cessation methods and services patients received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China.
- Being tested
- No intervention
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No drug will be administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Smokers or Recent Smoking Quitters who Have lung Surgery | The enrolled eligible participants, that is smokers or recent smoking quitters, will be assessed for the current smoking status and smoking cessation attempts during the perioperative period, to describe postoperative complications (PCs) including postoperative pulmonary complications (PPCs) following a lung surgery, and to describe the smoking cessation methods and services participants received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example nodule, ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery
Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.
Measured: Baseline Prior to the Surgery
Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Measured: Baseline Prior to the Surgery
Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Measured: Month 1 post-surgery
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Measured: Month 3 post-surgery
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Measured: Month 6 post-surgery
Number of Smoking Cessation Attempts at Baseline Prior to the Surgery
Number of smoking cessation attempts at baseline prior to the surgery will be reported.
Measured: Baseline prior to the surgery
Number of Smoking Cessation Attempts at Month 1 Post-surgery
Number of smoking cessation attempts at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Number of Smoking Cessation Attempts at Month 3 Post-surgery
Number of smoking cessation attempts at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Number of Smoking Cessation Attempts at Month 6 Post-surgery
Number of smoking cessation attempts at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline
Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.
Measured: Baseline
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.
Measured: Baseline prior to surgery
Percentage of Participants Using NRTs at Month 1 Post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Participants Using NRTs at Month 3 Post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.
Measured: Month 6 post-surgery
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery
Percentage of participants with self-reported smoking abstinence and 7-days/30-day point prevalence of smoking at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery
Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery
Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Percentage of Participants with Smoking Relapse at Month 1 Post-surgery
Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Participants with Smoking Relapse at Month 3 Post-surgery
Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Participants with Smoking Relapse at Month 6 Post-surgery
Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status
Overall incidence of PCs and PPCs post-surgery (at 1 day prior to discharge) and by baseline smoking status will be reported.
Measured: At 1 day prior to discharge
Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status
Overall incidence of PCs and PPCs post-surgery (within 2 weeks after surgery) and by baseline smoking status will be reported.
Measured: Within 2 weeks after surgery
Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status
Overall incidence of PCs and PPCs post-surgery (within 1 month post-surgery) and by baseline smoking status will be reported.
Measured: Within 1 month post-surgery
Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status
Overall incidence of PCs and PPCs post-surgery (within 3 months post-surgery) and by baseline smoking status will be reported.
Measured: Within 3 months post-surgery
Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status
Overall incidence of PCs and PPCs post-surgery (within 6 months post-surgery) and by baseline smoking status will be reported.
Measured: Within 6 months post-surgery
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery
Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.
Measured: Baseline prior to surgery
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at baseline prior to surgery will be reported.
Measured: Baseline prior to surgery
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at baseline prior to surgery will be reported.
Measured: Baseline prior to surgery
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 1 post-surgery will be reported.
Measured: Month 1 post-surgery
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 3 post-surgery will be reported.
Measured: Month 3 post-surgery
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 6 post-surgery will be reported.
Measured: Month 6 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start6 May 2020
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson (China) Investment Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson (China) Investment Ltd. Clinical Trial, Study director, Johnson & Johnson (China) Investment Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313361
- Sponsor's protocol ID
- CR108767
- Other IDs
- NOPRODLUC4001
- Acronym
- CHAMPION
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Observational Study of Smoking Cessation Patterns in Patients Undergoing Lung Surgery (CHAMPION Study)
- ClinicalTrials.gov ID
- NCT04313361
- Acronym / sponsor ID
- CHAMPION / CR108767
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Johnson & Johnson (China) Investment Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 18 Mar 2020 (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.
The purpose of this study is to assess the current smoking status and smoking cessation attempts among smokers or recent smoking quitters during the perioperative period, to describe postoperative pulmonary complications (PPCs) and other postoperative complications (PCs) following a lung surgery, and to describe the smoking cessation methods and services patients received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers or Recent Smoking Quitters who Have lung Surgery | – | Other: No interventionThe enrolled eligible participants, that is smokers or recent smoking quitters, will be assessed for the current smoking status and smoking cessation attempts during the perioperative period, to describe postoperative complications (PCs) including postoperative pulmonary complications (PPCs) following a lung surgery, and to describe the smoking cessation methods and services participants received from their health care professionals (HCPs) and participant's satisfaction among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion (example nodule, ground glass opacity) or other pulmonary conditions who are admitted to the thoracic surgical unit of the participating hospitals in China. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult participant with lung cancer, chronic obstructive pulmonary disorder (COPD), a pulmonary lesion, or other pulmonary conditions with a scheduled lung surgery and their treating health care providers (HCPs) from three participating hospitals in China.
Key inclusion criteria (3 listed)
- Participants who have been scheduled for an elective lung surgery by the treating physician's judgement, due to the following conditions: known lung cancer, COPD, a pulmonary lesion (example. nodule, ground glass opacity) or other pulmonary conditions
- Smokers who are or were smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years within 3 months prior to the scheduled surgery, or recent smoking quitters with a history of smoking on average no fewer than 5 cigarettes per day for equal or more than 3 years, who quit smoking between 3 months and 5 years prior to the scheduled surgery
- Being willing to participate the study and sign the participant informed consent form (ICF)
Key exclusion criteria (2 listed)
- Participants who have emergency lung surgery due to accident or injury
- Participants are not likely to be able to complete the 6-month follow-up after the lung surgery
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 |
|---|---|---|
| No interventionNo drug will be administered as part of this study. | Other | Smokers or Recent Smoking Quitters who Have lung Surgery |
Primary outcome
Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery
Time frame: Baseline Prior to the Surgery
Percentage of smokers and recent smoking quitters at baseline prior to the surgery will be reported.
Smoking Dependence Among Smokers as Measured by Fagerstrom Test of Nicotine Dependence (FTND) Scale at Baseline Prior to the Surgery
Time frame: Baseline Prior to the Surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Smoking Dependence Among Smokers as Measured by FTND Scale at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 3 Post-surgery
Time frame: Month 3 post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Smoking Dependence Among Smokers as Measured by FTND Scaleat Month 6 Post-surgery
Time frame: Month 6 post-surgery
Level of smoking dependence will be measured by FTND Scale in the participant's questionnaire. FTND is a 6-item self-report measure of nicotine dependence derived from the Fagerström Tolerance Questionnaire, which comprises yes/no options (scored from 0 to 1) and multiple-choice items (scored from 0 to 3). The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the participant's physical dependence on nicotine.
Number of Smoking Cessation Attempts at Baseline Prior to the Surgery
Time frame: Baseline prior to the surgery
Number of smoking cessation attempts at baseline prior to the surgery will be reported.
Number of Smoking Cessation Attempts at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Number of smoking cessation attempts at Month 1 post-surgery will be reported.
Number of Smoking Cessation Attempts at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Number of smoking cessation attempts at Month 3 post-surgery will be reported.
Number of Smoking Cessation Attempts at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Number of smoking cessation attempts at Month 6 post-surgery will be reported.
Number of Participants who Used Methods and Medications for Smoking Cessation at Baseline
Time frame: Baseline
Number of participants who used prior methods and medications for smoking cessation at baseline will be reported.
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 1 post-surgery will be reported.
Number of Participants who Used Current Methods and Medications for Smoking Cessation at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 3 post-surgery will be reported.
Number of Participants who Used Prior Methods and Medications for Smoking Cessation at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Number of participants who used current methods or medication for smoking cessation at Month 6 post-surgery will be reported.
Percentage of Participants Using Nicotine Replacement Therapy (NRTs) at Baseline Prior to Surgery
Time frame: Baseline prior to surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at baseline prior to surgery will be reported.
Percentage of Participants Using NRTs at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 1 post surgery will be reported.
Percentage of Participants Using NRTs at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 3 post surgery will be reported.
Percentage of Participants Using NRTs, Types of NRTs Used and Perceived Effectiveness at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Percentage of participants using NRTs, types of NRTs used and perceived effectiveness, at Month 6 post surgery will be reported.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Percentage of participants with self-reported smoking abstinence and 7-days/30-day point prevalence of smoking at Month 1 post-surgery will be reported.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 3 post-surgery will be reported.
Percentage of Participants with Self-reported Smoking Abstinence and Point Prevalence at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Percentage of participants with self-reported smoking abstinence and point prevalence of smoking at Month 6 post-surgery will be reported.
Percentage of Participants with Smoking Relapse at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Percentage of participants with smoking relapse at Month 1 post-surgery will be reported.
Percentage of Participants with Smoking Relapse at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Percentage of participants with smoking relapse at Month 3 post-surgery will be reported.
Percentage of Participants with Smoking Relapse at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Percentage of participants with smoking relapse at Month 6 post-surgery will be reported.
Overall Incidence of Postoperative Complications (PCs) and Postoperative Pulmonary Complications (PPCs) Post-surgery (at 1 Day Prior to Discharge)and by Baseline Smoking Status
Time frame: At 1 day prior to discharge
Overall incidence of PCs and PPCs post-surgery (at 1 day prior to discharge) and by baseline smoking status will be reported.
Overall Incidence of PCs and PPCs Post-surgery (Within 2 Weeks After Surgery) and by Baseline Smoking Status
Time frame: Within 2 weeks after surgery
Overall incidence of PCs and PPCs post-surgery (within 2 weeks after surgery) and by baseline smoking status will be reported.
Overall Incidence of PCs and PPCs Post-surgery (Within 1 Month Post-surgery) and by Baseline Smoking Status
Time frame: Within 1 month post-surgery
Overall incidence of PCs and PPCs post-surgery (within 1 month post-surgery) and by baseline smoking status will be reported.
Overall Incidence of PCs and PPCs Post-surgery (Within 3 Months Post-surgery) and by Baseline Smoking Status
Time frame: Within 3 months post-surgery
Overall incidence of PCs and PPCs post-surgery (within 3 months post-surgery) and by baseline smoking status will be reported.
Overall Incidence of PCs and PPCs Post-surgery (Within 6 Months Post-surgery) and by Baseline Smoking Status
Time frame: Within 6 months post-surgery
Overall incidence of PCs and PPCs post-surgery (within 6 months post-surgery) and by baseline smoking status will be reported.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Baseline Prior to Surgery
Time frame: Baseline prior to surgery
Percentage of participants who received advice from HCPs to quit smoking at baseline prior to surgery will be reported.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 1 post-surgery will be reported.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 3 post-surgery
Time frame: Month 3 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 3 post-surgery will be reported.
Percentage of Participants who Received Advice from HCPs to Quit Smoking at Month 6 post-surgery
Time frame: Month 6 post-surgery
Percentage of participants who received advice from HCPs to quit smoking at Month 6 post-surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
Time frame: Baseline prior to surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at baseline prior to surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Baseline Prior to Surgery
Time frame: Month 1 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 1 post-surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 3 post-surgery
Time frame: Month 3 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 3 post-surgery will be reported.
Percentage of Specific Smoking Cessation Methods and Service Participants Received from HCPs at Month 6 post-surgery
Time frame: Month 6 post-surgery
Percentage of specific smoking cessation methods and service participants received from HCPs at Month 6 post-surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Baseline Prior to Surgery
Time frame: Baseline prior to surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at baseline prior to surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 1 Post-surgery
Time frame: Month 1 post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 1 post-surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 3 Post-surgery
Time frame: Month 3 post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 3 post-surgery will be reported.
Percentage of Participant's Satisfaction on the Smoking Cessation Methods Received from HCPs at Month 6 Post-surgery
Time frame: Month 6 post-surgery
Percentage of participant's satisfaction on the smoking cessation methods received from HCPs at Month 6 post-surgery will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Johnson & Johnson (China) Investment Ltd. Clinical Trial study director
Johnson & Johnson (China) Investment Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Johnson & Johnson (China) Investment Ltd. at 3 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Smokers and Recent Smoking Quitters at Baseline Prior to the Surgery (time frame: Baseline Prior to the Surgery). The study lists 40 primary outcomes in all. 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 27 Apr 2025.