NSCLCNeoIM-LungNCT06317558
Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy
An observational study of NSCLC, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Neoadjuvant immunotherapy and Other drugs for neoadjuvant treatment
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2034
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC patients receiving neoadjuvant immunotherapy.
Who may be able to join
- Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
- Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
- No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
- At least one measurable lesion (RECIST v1.1).
Who cannot join
- Patients included in unblinded clinical trials or anti-tumor drug intervention.
- Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
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
Shugeng Gao
Beijing, Beijing Municipality, 100020
Shugeng Gao, MD, 010-87788177, gaoshugeng@cicams.ac.cn
About this study
Official title: Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)
The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:
- What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
- How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.
Read the detailed description
The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:
- What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?
- How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.
- Conditions
- NSCLC
- Being tested
- Neoadjuvant immunotherapy, Other drugs for neoadjuvant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant immunotherapyDrug
Also called Immune checkpoint inhibitors
Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.
Other drugs for neoadjuvant treatmentDrug
Also called Other drugs
Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant immunotherapy | Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. Receives: Drug: Neoadjuvant immunotherapy | |
| Other neoadjuvant treatment | Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. Receives: Drug: Other drugs for neoadjuvant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
defined as 0% of viable tumor cells in primary tumor and lymph nodes
Measured: Within 15 days after surgery
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 date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 years.
Secondary outcomes (4)
Overall survival (OS)
OS is defined as the time from surgery time until death from any cause.
Measured: From date of surgery until date of death due to any cause, up to approximately 10 years.
Event-free survival (EFS)
EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Measured: EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.
Major Pathological Response (MPR)
defined as ≤10% of viable tumor cells
Measured: Within 15 days after surgery
Relapse Patterns
Relapse was defined as disease recurrence at any site.
Measured: Within 10 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 posted19 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shugeng Gao, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317558
- Sponsor's protocol ID
- 22/492-3694
- Acronym
- NeoIM-Lung
- Status last verified
- Jun 2024
- First submitted
- 12 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)
- ClinicalTrials.gov ID
- NCT06317558
- Acronym / sponsor ID
- NeoIM-Lung / 22/492-3694
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 19 Mar 2024 (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 goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:
- What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
- How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.
Detailed description
The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:
- What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy?
- How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant immunotherapy | – | Drug: Neoadjuvant immunotherapyImmune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. |
| Other neoadjuvant treatment | – | Drug: Other drugs for neoadjuvant treatmentOther drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients receiving neoadjuvant immunotherapy.
Key inclusion criteria (5 listed)
- Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
- Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
- No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
- At least one measurable lesion (RECIST v1.1).
Key exclusion criteria (2 listed)
- Patients included in unblinded clinical trials or anti-tumor drug intervention.
- Radiotherapy or systemic therapy were used for NSCLC patients before the 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 |
|---|---|---|
| Neoadjuvant immunotherapyAlso: Immune checkpoint inhibitorsImmune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients. | Drug | Neoadjuvant immunotherapy |
| Other drugs for neoadjuvant treatmentAlso: Other drugsDrugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC. | Drug | Other neoadjuvant treatment |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Within 15 days after surgery
defined as 0% of viable tumor cells in primary tumor and lymph nodes
Disease-free survival (DFS)
Time frame: DFS was defined as the time from surgery to the date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 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).
4 secondary outcomes
Overall survival (OS)
Time frame: From date of surgery until date of death due to any cause, up to approximately 10 years.
Event-free survival (EFS)
Time frame: EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.
Major Pathological Response (MPR)
Time frame: Within 15 days after surgery
Relapse Patterns
Time frame: Within 10 years after surgery
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 3 Jul 2024.
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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.
Shugeng Gao, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 NSCLC, 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 5 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: looking for participants now, as of the sponsor's last update on 3 Jul 2024. 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 Shugeng Gao, MD (8610-87788177, gaoshugeng@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Within 15 days after surgery). 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?
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 Jul 2024.