Lung Squamous Cell Carcinoma Stage IVNCT04306042
A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy
An observational study of Lung Squamous Cell Carcinoma Stage IV, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Squamous Cell Carcinoma Stage IV
- What is being tested?
- Nivolumab or Pembrolizumab
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2020to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers.
Who may be able to join
- Men and woman, aged over 18
- Cytology or histologically confirmed squamous cell lung cancer
- Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8)
- Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition
- Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days)
- Have imaging results with measurable tumor 2 weeks before receiving PD-1 mAb in combination with chemotherapy
- Able to understand and comply with the requirements of the consent and voluntarily participate in the study
Who cannot join
- Patients participating in other clinical studies
- Severe medical data missing
- Unable to understand the purpose of the study or not agree with the requirement of the study
- Malignancies other than squamous cell lung cancer, history of malignancies
- Unsuitable for the study according to investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Chongrui Xu
About this study
Official title: A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)
This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management.
In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision.
After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.
- Conditions
- Lung Squamous Cell Carcinoma Stage IV
- Being tested
- Nivolumab or Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab or PembrolizumabDrug
Nivolumab or Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers between 01 September 2019 and 30 June 2020 will be targeted for study inclusion. Receives: Drug: Nivolumab or Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year survival rate
Measured: 2 years
objective response rate
Measured: 2 years
disease control rate
free survival
Measured: 2 years
median progression free survival
Measured: 2 years
Secondary outcomes (1)
incidence of adverse reactions
Safety of the combination of PD-1 and chemotherapy
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 posted12 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Squamous Cell Carcinoma Stage IVStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306042
- Sponsor's protocol ID
- CTONG1904
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients information without identification data will be shared within centers enrolled in the study to perform the data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)
- ClinicalTrials.gov ID
- NCT04306042
- Acronym / sponsor ID
- CTONG1904
- Conditions
- Lung Squamous Cell Carcinoma Stage IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 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.
This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management.
In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision.
After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Nivolumab or PembrolizumabPatients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers between 01 September 2019 and 30 June 2020 will be targeted for study inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers.
Key inclusion criteria (7 listed)
- Men and woman, aged over 18
- Cytology or histologically confirmed squamous cell lung cancer
- Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8)
- Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition
- Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days)
Key exclusion criteria (5 listed)
- Patients participating in other clinical studies
- Severe medical data missing
- Unable to understand the purpose of the study or not agree with the requirement of the study
- Malignancies other than squamous cell lung cancer, history of malignancies
- Unsuitable for the study according to investigator
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 |
|---|---|---|
| Nivolumab or PembrolizumabNivolumab or Pembrolizumab | Drug | Treatment |
Primary outcome
2 year survival rate
Time frame: 2 years
objective response rate
Time frame: 2 years
disease control rate
Time frame: 2 years
free survival
median progression free survival
Time frame: 2 years
1 secondary outcome
incidence of adverse reactions
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Yes. Patients information without identification data will be shared within centers enrolled in the study to perform the data analysis.
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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.
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 Squamous Cell Carcinoma Stage IV, run by Guangdong Association of Clinical Trials 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 7 inclusion and 5 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 12 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chongrui Xu (86-20-838278812 ext. 50816, xucr001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year survival rate (time frame: 2 years). The study lists 4 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 12 Mar 2020.