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

NCT ID: NCT07256002

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2027-12-01

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:

1. Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?

2. 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?

3. 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.)?

4. Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?

Detailed Description

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:

1. Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?

2. 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?

3. 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.)?

4. 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

PD-1 Inhibitors

Adjuvant PD-1 inhibitor maintenance therapy

Intervention Type: DRUG

Chemotherapy

Postoperative chemotherapy as an adjuvant treatment

Intervention Type: DRUG

PD-1 inhibitors combined with chemotherapy

Postoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who visited the hospital from January 2020 to December 2023;

2. Received neoadjuvant immunotherapy before surgery;

3. Histologically diagnosed with stage II-III NSCLC;

4. Had measurable lesions as assessed by the investigator using the RECIST 1.1 version;

5. Underwent radical surgical treatment;

6. ECOG score of 0 or 1;

7. Available tumor tissue samples;

8. Good blood and organ functions.

Exclusion Criteria

1. 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);

2. Has a history of previous malignant tumors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shugeng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NCC5704

Identifier Type: -

Identifier Source: org_study_id