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

NCT07256002 | Active Not Recruiting

• 1 other identifier: NCC5704
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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. 1.Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
2. 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. 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. 4.Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Event-free survival(EFS)

  up to 7 years and 11 months.

• Pathological Complete Response(pCR)

  up to 1 month after surgery

Interventions

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Immune Checkpoint Inhibitors; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Officials

• Shugeng Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 1, 2025
• Study Start: January 1, 2020
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-09

Locations

CN (1)