Lung Cancer (NSCLC)NCT07256002

Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy

An observational study of Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The aim of this observational study is to investigate the survival differences among patients with non-small cell lung cancer who received different adjuvant treatments after neoadjuvant immunotherapy, and to identify the main clinical characteristics of these survival differences. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Lung Cancer (NSCLC)
What is being tested?: PD-1 Inhibitors, Chemotherapy and PD-1 inhibitors combined with chemotherapy
How many people: 10,000 participants
Where: 1 siteChina
Study dates: 1 Jan 2020to 1 Dec 2027
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 18 to 85 years
All sexes
Adult, Older adult

Study population: Patients with lung cancer who have received neoadjuvant immunotherapy and surgery.

Who may be able to join

Patients who visited the hospital from January 2020 to December 2023;
Received neoadjuvant immunotherapy before surgery;
Histologically diagnosed with stage II-III NSCLC;
Had measurable lesions as assessed by the investigator using the RECIST 1.1 version;
Underwent radical surgical treatment;
ECOG score of 0 or 1;
Available tumor tissue samples;
Good blood and organ functions.

Who cannot join

Has received other anti-tumor treatments before, including radiotherapy, chemotherapy and traditional Chinese medicine-based cancer treatment (except for malignant tumor treatments that have been cured and have no recurrence or metastasis for more than 5 years);
Has a history of previous malignant tumors.

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy:A Real World Multicenter Retrospective Study

Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out?
Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)?
Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?

Read the detailed description

Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out?
Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)?
Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy? Participants will undergo neoadjuvant immunotherapy and surgical procedures, and through rigorous analysis of real-world 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 (NSCLC)
Being tested: PD-1 Inhibitors, Chemotherapy, PD-1 inhibitors combined with chemotherapy
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PD-1 InhibitorsDrug
Adjuvant PD-1 inhibitor maintenance therapy
ChemotherapyDrug
Postoperative chemotherapy as an adjuvant treatment
PD-1 inhibitors combined with chemotherapyDrug
Postoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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 7 years and 11 months.

Secondary outcomes (2)

Event-free survival(EFS)
Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis.
Measured: up to 7 years and 11 months.
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20201 Dec 2027

First posted1 Dec 2025
Study start1 Jan 2020
Primary completion1 Dec 2023
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Cancer (NSCLC)Studies 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: Other
Enrolment: 10,000 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07256002
Sponsor's protocol ID: NCC5704
Status last verified: Sep 2025
First submitted: 28 Sep 2025
Last updated: 1 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer (NSCLC) trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy:A Real World Multicenter Retrospective Study
ClinicalTrials.gov ID: NCT07256002
Acronym / sponsor ID: NCC5704
Conditions: Lung Cancer (NSCLC)
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 10,000 participants (estimated)
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2027 (estimated)
First posted: 1 Dec 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.

Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out?
Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)?
Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?

Detailed description

Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out?
Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)?
Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy? Participants will undergo neoadjuvant immunotherapy and surgical procedures, and through rigorous analysis of real-world 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: Other
Target follow-up: 5 Years

Who may qualify

Ages: 18 to 85 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients with lung cancer who have received neoadjuvant immunotherapy and surgery.

Key inclusion criteria (8 listed)

Patients who visited the hospital from January 2020 to December 2023;
Received neoadjuvant immunotherapy before surgery;
Histologically diagnosed with stage II-III NSCLC;
Had measurable lesions as assessed by the investigator using the RECIST 1.1 version;
Underwent radical surgical treatment;

Key exclusion criteria (2 listed)

Has received other anti-tumor treatments before, including radiotherapy, chemotherapy and traditional Chinese medicine-based cancer treatment (except for malignant tumor treatments that have been cured and have no recurrence or metastasis for more than 5 years);
Has a history of previous malignant tumors.

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
PD-1 InhibitorsAdjuvant PD-1 inhibitor maintenance therapy	Drug	–
ChemotherapyPostoperative chemotherapy as an adjuvant treatment	Drug	–
PD-1 inhibitors combined with chemotherapyPostoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy	Drug	–

Primary outcome

Overall Survival (OS)
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 7 years and 11 months.
OS is defined as the time from surgery time until death from any cause.

2 secondary outcomes

Event-free survival(EFS)
Time frame: up to 7 years and 11 months.
Pathological Complete Response(pCR)
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 1 Dec 2025.

Related trials for Lung Cancer (NSCLC)

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

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 Lung Cancer (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 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: under way, not looking for participants, as of the sponsor's last update on 1 Dec 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?

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?

Overall Survival (OS) (time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 7 years and 11 months.). 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 NCT07256002.

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 1 Dec 2025.