Non Small Cell Lung CancerNCT05637580
Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC
An observational study of Non Small Cell Lung Cancer and Immunotherapy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Immunotherapy, Chemotherapy
- What is being tested?
- Timing of drug administration
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 1 Jul 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 with stage II-III NSCLC who received neoadjuvant immunochemotherapy (time) in Guangdong Provincial People's Hospital were eligible for this study. We also included early-stage NSCLC patients who were unsuitable or unable to tolerate surgery after first evaluation. Eligible patients were 18 years of age or older, had a karnofsky performance status (KPS) score of 100 or 90 (on a scale from 0 to 100 with higher score indicating better ability to carry out daily activities). Patients with distant tumor metastasis or with known ALK translocations or EGFR mutations were excluded.
Who may be able to join
- Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
- early-stage NSCLC patients who were initially unresectable.
- 18 years of age or older.
- Karnofsky performance status (KPS) score of 100 or 90.
Who cannot join
- Patients with stage IV NSCLC
- Patients with known ALK translocations or EGFR mutations.
- Karnofsky performance status (KPS) score <90.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer
This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.
- Being tested
- Timing of drug administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of drug administrationDrug
The effect of drug administration timing on tumor and lymph node responses was observed.
| Study group | Role | What they receive |
|---|---|---|
| combined well responder | Both primary tumor and nodal response achieve major pathological response (MPR). Receives: Drug: Timing of drug administration | |
| poor responder | Primary tumor or/and nodal response can not achieve MPR. Receives: Drug: Timing of drug administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.
Measured: At least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 May 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guibin Qiao, MD, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637580
- Sponsor's protocol ID
- LUNGTN
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05637580
- Acronym / sponsor ID
- LUNGTN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Dec 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 is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined well responder | – | Drug: Timing of drug administrationBoth primary tumor and nodal response achieve major pathological response (MPR). |
| poor responder | – | Drug: Timing of drug administrationPrimary tumor or/and nodal response can not achieve MPR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage II-III NSCLC who received neoadjuvant immunochemotherapy (time) in Guangdong Provincial People's Hospital were eligible for this study. We also included early-stage NSCLC patients who were unsuitable or unable to tolerate surgery after first evaluation. Eligible patients were 18 years of age or older, had a karnofsky performance status (KPS) score of 100 or 90 (on a scale from 0 to 100 with higher score indicating better ability to carry out daily activities). Patients with distant tumor metastasis or with known ALK translocations or EGFR mutations were excluded.
Key inclusion criteria (4 listed)
- Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
- early-stage NSCLC patients who were initially unresectable.
- 18 years of age or older.
- Karnofsky performance status (KPS) score of 100 or 90.
Key exclusion criteria (3 listed)
- Patients with stage IV NSCLC
- Patients with known ALK translocations or EGFR mutations.
- Karnofsky performance status (KPS) score <90.
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 |
|---|---|---|
| Timing of drug administrationThe effect of drug administration timing on tumor and lymph node responses was observed. | Drug | combined well responder, poor responder |
Primary outcome
Event-free survival
Time frame: At least one year
the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.
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 5 Dec 2022.
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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.
Guibin Qiao, MD study director
Guangdong Provincial People's Hospital
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 Non Small Cell Lung Cancer and Immunotherapy, run by Guangdong Provincial People's 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 4 inclusion and 3 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 5 Dec 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.
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?
Event-free survival (time frame: At least one year). 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 5 Dec 2022.