Lung Cancer, Non-Small CellNeoIP-LungNCT07166003
Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer
An observational study of Lung Cancer, Non-Small Cell and Immunotherapy, 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 learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are: Does pneumonectomy bring more benefits for pateints than lobectomy? Does surgery bring more benefits for patients than non-surgery modalities… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lung Cancer, Non-Small Cell, Immunotherapy
- What is being tested?
- Pneumonectomy, lobectomy and radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 14 Apr 2030
- 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 79 years
- All sexes
- Adult, Older adult
Study population: Patients with lung cancer who receive neoadjuvant immunotherapy.
Who may be able to join
- Aged between 18 and 79 years;
- Received at least two cycles of neoadjuvant immunotherapy;
- ECOG performance status score of 0;
- Complete clinical information including imaging data available.
Who cannot join
- Diagnosed with or suspected active autoimmune diseases;
- Presence of EGFR/ALK sensitive mutations;
- Pregnant or breastfeeding women;
- Previous anti-tumor therapies including chemotherapy or radiotherapy;
- History of organ transplantation or hematopoietic stem cell transplantation;
- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
- Uncontrolled diabetes mellitus;
- Uncontrolled hypertension.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Shugeng Gao, MD, 8610-87788177, guowei@cicams.ac.cn
About this study
Official title: Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study
The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are:
- Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.
Read the detailed description
This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.
- Conditions
- Lung Cancer, Non-Small Cell, Immunotherapy
- Being tested
- Pneumonectomy, lobectomy, radiotherapy, Anti-Tumor Drugs
- 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.
PneumonectomyProcedure or surgery
Patients will receive pneumonectomy after neoadjuvant treatment
lobectomyProcedure or surgery
Patients will receive lobectomy after neoadjuvant immunotherapy.
radiotherapyRadiation
Patients will receive radiotherapy after neoadjuvant immunotherapy.
Anti-Tumor DrugsDrug
Patients will receive anti-tumor drugs.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Patients will undergo surgery after neoadjuvant immunotherapy. Receives: Procedure: Pneumonectomy; Procedure: lobectomy | |
| Non-surgery | Patients will receive non-surgical treatment after neoadjuvant treatment. Receives: Radiation: radiotherapy; Drug: Anti-Tumor Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.
Secondary outcomes (2)
Overall survival
Measured: From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.
Perioperative Complication rate
Complications after the neoadjuvant treatment.
Measured: Within 6 months after neoadjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Apr 2025
- Primary completion2 Feb 2027 (estimated)
- Study completion14 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166003
- Sponsor's protocol ID
- 2025040620521402
- Acronym
- NeoIP-Lung
- Status last verified
- Apr 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07166003
- Acronym / sponsor ID
- NeoIP-Lung / 2025040620521402
- Conditions
- Lung Cancer, Non-Small Cell, Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 14 Apr 2030 (estimated)
- First posted
- 10 Sep 2025 (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 learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are:
- Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.
Detailed description
This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: Pneumonectomy, Procedure: lobectomyPatients will undergo surgery after neoadjuvant immunotherapy. |
| Non-surgery | – | Radiation: radiotherapy, Drug: Anti-Tumor DrugsPatients will receive non-surgical treatment after neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer who receive neoadjuvant immunotherapy.
Key inclusion criteria (4 listed)
- Aged between 18 and 79 years;
- Received at least two cycles of neoadjuvant immunotherapy;
- ECOG performance status score of 0;
- Complete clinical information including imaging data available.
Key exclusion criteria (8 listed)
- Diagnosed with or suspected active autoimmune diseases;
- Presence of EGFR/ALK sensitive mutations;
- Pregnant or breastfeeding women;
- Previous anti-tumor therapies including chemotherapy or radiotherapy;
- History of organ transplantation or hematopoietic stem cell transplantation;
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 |
|---|---|---|
| PneumonectomyPatients will receive pneumonectomy after neoadjuvant treatment | Procedure or surgery | Surgery |
| lobectomyPatients will receive lobectomy after neoadjuvant immunotherapy. | Procedure or surgery | Surgery |
| radiotherapyPatients will receive radiotherapy after neoadjuvant immunotherapy. | Radiation | Non-surgery |
| Anti-Tumor DrugsPatients will receive anti-tumor drugs. | Drug | Non-surgery |
Primary outcome
Event-free survival
Time frame: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.
2 secondary outcomes
Overall survival
Time frame: From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.
Perioperative Complication rate
Time frame: Within 6 months after neoadjuvant treatment.
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 10 Sep 2025.
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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.
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 Cancer, Non-Small Cell and Immunotherapy, 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 4 inclusion and 8 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 10 Sep 2025. 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?
Event-free survival (time frame: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.). 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 10 Sep 2025.