Non-Small Cell Lung CancerNeoR-WorldNCT05974007
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC
An observational study of Non-Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Neoadjuvant immunochemotherapy and Neoadjuvant chemotherapy
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jun 2026
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stage I-III NSCLC patients undergo neoadjuvant treatment.
Who may be able to join
- Cytological or histological diagnosis of non-small cell lung cancer
- Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
- Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
- No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
- At least one measurable lesion (RECIST v1.1);
- Age >= 18 years old and <= 85 years old;
- Be able to abide by the visits and related procedures stipulated in the program.
Who cannot join
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Jie He, Dr., 010-87788863, prof.jiehe@gmail.com
About this study
Official title: Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.
Read the detailed description
Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.
To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Neoadjuvant immunochemotherapy, Neoadjuvant chemotherapy
- Keywords
- NSCLC, Neoadjuvant immunochemotherapy, Neoadjuvant chemotherapy, Real world study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant immunochemotherapyDrug
Also called Neoadjuvant immunotherapy
Patients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery
Neoadjuvant chemotherapyDrug
Also called Neoadjuvant platinum-based doublet chemotherapy
Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery
| Study group | Role | What they receive |
|---|---|---|
| Resectable stage I-III NSCLC | Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist. Receives: Drug: Neoadjuvant immunochemotherapy; Drug: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival(DFS)
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Measured: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
Pathological Complete Response (pCR)
defined as 0% of viable tumor cells in primary tumor and lymph nodes
Measured: Within 2 weeks after surgery
Secondary outcomes (10)
OS (overall survival)
OS is defined as the time from surgery tiem until death from any cause.
Measured: From date of surgery until date of death due to any cause, up to approximately 5 years.
Overall Survival (overall survival) Rate
OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
Measured: From date of surgery until date of death due to any cause. Assessed at 1 years.
Overall Survival (overall survival) Rate
OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
Measured: From date of surgery until date of death due to any cause. Assessed at 2 years.
Overall Survival (overall survival) Rate
OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis.
Measured: From date of surgery until date of death due to any cause. Assessed at 5 years.
EFS (event-free survival)
EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Measured: Up to 5 years after first therapy.
Event Free Survival (event-free survival) Rate
EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Measured: From date of first received neoadjuvant therapy to 1 years after neoadjuvant.
Event Free Survival (event-free survival) Rate
EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Measured: From date of first received neoadjuvant therapy to 2 years after neoadjuvant.
Event Free Survival (event-free survival) Rate
EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Measured: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.
Major Pathological Response (MPR)
defined as ≤10% of viable tumor cells
Measured: Within 2 weeks after surgery
Patterns of Relapse
Relapse was defined as disease recurrence at any site.
Measured: Within 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jan 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jun 2026 (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 Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie He, Dr., Study chair, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974007
- Sponsor's protocol ID
- 22/093-3294
- Acronym
- NeoR-World
- Status last verified
- May 2023
- First submitted
- 19 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yang Z, Wang S, Yang H, Jiang Y, Zhu L, Zheng B, Fu H, Ma J, Xie H, Wang Z, He H, Xia C, Li R, Xu J, Han J, Huang X, Li Y, Zhao B, Ni C, Xing H, Chen Y, Wang J, Jiang Y, Song Y, Mao Y, Chen C, Yao F, Zhang G, Hu J, Xue Q, Gao S, He J; NeoR-World Research Group. Treatment patterns and clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant immunochemotherapy: A large-scale, multicenter, real-world study (NeoR-World). J Thorac Cardiovasc Surg. 2024 Oct;168(4):1245-1258.e17. doi: 10.1016/j.jtcvs.2024.02.006. Epub 2024 Feb 10.
PubMed 38342430
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
- ClinicalTrials.gov ID
- NCT05974007
- Acronym / sponsor ID
- NeoR-World / 22/093-3294
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Neoadjuvant immunochemotherapy, Neoadjuvant chemotherapy, Real world study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Aug 2023 (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.
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.
Detailed description
Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.
To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resectable stage I-III NSCLC | – | Drug: Neoadjuvant immunochemotherapy, Drug: Neoadjuvant chemotherapyPatients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stage I-III NSCLC patients undergo neoadjuvant treatment.
Key inclusion criteria (8 listed)
- Cytological or histological diagnosis of non-small cell lung cancer
- Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
- Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
- No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
Key exclusion criteria (2 listed)
- Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
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 |
|---|---|---|
| Neoadjuvant immunochemotherapyAlso: Neoadjuvant immunotherapyPatients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery | Drug | Resectable stage I-III NSCLC |
| Neoadjuvant chemotherapyAlso: Neoadjuvant platinum-based doublet chemotherapyPatients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery | Drug | Resectable stage I-III NSCLC |
Primary outcome
Disease-free survival(DFS)
Time frame: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Pathological Complete Response (pCR)
Time frame: Within 2 weeks after surgery
defined as 0% of viable tumor cells in primary tumor and lymph nodes
10 secondary outcomes
OS (overall survival)
Time frame: From date of surgery until date of death due to any cause, up to approximately 5 years.
Overall Survival (overall survival) Rate
Time frame: From date of surgery until date of death due to any cause. Assessed at 1 years.
Overall Survival (overall survival) Rate
Time frame: From date of surgery until date of death due to any cause. Assessed at 2 years.
Overall Survival (overall survival) Rate
Time frame: From date of surgery until date of death due to any cause. Assessed at 5 years.
EFS (event-free survival)
Time frame: Up to 5 years after first therapy.
Event Free Survival (event-free survival) Rate
Time frame: From date of first received neoadjuvant therapy to 1 years after neoadjuvant.
Event Free Survival (event-free survival) Rate
Time frame: From date of first received neoadjuvant therapy to 2 years after neoadjuvant.
Event Free Survival (event-free survival) Rate
Time frame: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.
Major Pathological Response (MPR)
Time frame: Within 2 weeks after surgery
Patterns of Relapse
Time frame: Within 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 38342430Yang Z, Wang S, Yang H, Jiang Y, Zhu L, Zheng B, Fu H, Ma J, Xie H, Wang Z, He H, Xia C, Li R, Xu J, Han J, Huang X, Li Y, Zhao B, Ni C, Xing H, Chen Y, Wang J, Jiang Y, Song Y, Mao Y, Chen C, Yao F, Zhang G, Hu J, Xue Q, Gao S, He J; NeoR-World Research Group. Treatment patterns and clinical outcomes of patients with resectable non-small cell lung cancer receiving neoadjuvant immunochemotherapy: A large-scale, multicenter, real-world study (NeoR-World). J Thorac Cardiovasc Surg. 2024 Oct;168(4):1245-1258.e17. doi: 10.1016/j.jtcvs.2024.02.006. Epub 2024 Feb 10.
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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.
Jie He, Dr. study chair
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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 Jie He, Dr. (010-87788863, prof.jiehe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival(DFS) (time frame: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.). The study lists 2 primary outcomes in all. 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 NCT05974007, 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 3 Aug 2023.