Carcinoma, Non-Small-Cell LungNCT07373899
Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study
An observational study of Carcinoma, Non-Small-Cell Lung and Neoadjuvant Immunotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy, Surgery
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients were those admitted to the Thoracic Surgery Department of the Cancer Hospital of Chinese Academy of Medical Sciences.
Who may be able to join
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy
- Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment
- Age ≥ 18 years
- ECOG performance status score of 0-1
- Complete imaging, pathological, and follow-up data available
Who cannot join
- Disease progression (PD) after neoadjuvant therapy
- Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent
- Intraoperative findings indicating that R0 resection was not feasible
- Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate 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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Chaoyang, 250101
About this study
This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgery Group | Perform a pneumonectomy or composite lobectomy within the originally planned scope | |
| Modified/Reduced Surgery Group | Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.
Measured: Evaluate over a period of up to five years
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from surgery time until death from any cause.
Measured: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.
Pathological Complete Response(pCR)
After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found.
Measured: up to 1 month after surgery
Incidence of perioperative complications
The perioperative period refers to a certain period before, during and after the surgery. Postoperative pulmonary complications refer to various respiratory system complications that occur in patients after the surgery.
Measured: up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 354 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373899
- Sponsor's protocol ID
- NCC5959
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2026
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study
- ClinicalTrials.gov ID
- NCT07373899
- Acronym / sponsor ID
- NCC5959
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Jan 2026 (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 study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgery Group | – | –Perform a pneumonectomy or composite lobectomy within the originally planned scope |
| Modified/Reduced Surgery Group | – | –Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients were those admitted to the Thoracic Surgery Department of the Cancer Hospital of Chinese Academy of Medical Sciences.
Key inclusion criteria (6 listed)
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy
- Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment
- Age ≥ 18 years
- ECOG performance status score of 0-1
Key exclusion criteria (4 listed)
- Disease progression (PD) after neoadjuvant therapy
- Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent
- Intraoperative findings indicating that R0 resection was not feasible
- Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: Evaluate over a period of up to five years
It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.
3 secondary outcomes
Overall Survival (OS)
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.
Pathological Complete Response(pCR)
Time frame: up to 1 month after surgery
Incidence of perioperative complications
Time frame: up to 1 month 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 24 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carcinoma, Non-Small-Cell Lung and Neoadjuvant 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. 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?
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?
Disease-free survival (time frame: Evaluate over a period of up to five 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 24 Jul 2026.