Survival Analysis and Prognostic Biomarker Exploration of... | NCT07256002

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

NCT07256002

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Active, not recruiting

Last Update Posted

Dec 1, 2025Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Lung Cancer (NSCLC)

Interventions

PD-1 Inhibitors
Chemotherapy
PD-1 inhibitors combined with chemotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Sep 28, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2025

Last Update Posted Date

Dec 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The main question it aims to answer is:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
PD-1 Inhibitors	Drug	Adjuvant PD-1 inhibitor maintenance therapy
Chemotherapy	Drug	Postoperative chemotherapy as an adjuvant treatment
PD-1 inhibitors combined with chemotherapy	Drug	Postoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from surgery time until death from any cause.	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

Measure	Description	Time Frame
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.	up to 7 years and 11 months.
Pathological Complete Response(pCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shugeng Gao, MD	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital, Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100020	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms

ID	Term
D000082082	Immune Checkpoint Inhibitors
D004358	Drug Therapy

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000074322	Antineoplastic Agents, Immunological
D000970	Antineoplastic Agents
D045506	Therapeutic Uses
D013812	Therapeutics