Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer

NCT06926179 | Recruiting DMC

• 1 other identifier: 10412
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.

Conditions

Lung Cancer (NSCLC); Neoadjuvant Immunotherapy; Radiotherapy; Lung Surgery

Keywords

lung cancer; neoadjuvant immunotherapy; real-world study; radiotherapy; thoracic surgery

Outcome Measures

Primary Outcomes (2)

• Technical Dissection Difficulty (TDD) Rate

  Defined as the intraoperative presence of fibrosis and/or tight adhesion between lymph nodes and surrounding structures around the hilar and fissure. TDD is considered present if either fibrosis or significant adhesion is noted, potentially increasing surgical complexity. Surgical difficulty is assessed based on operative reports and predefined intraoperative criteria, as documented by the operating surgeon.

  During the radical surgery (Day 0 of surgery)

• Disease-Free Survival (DFS)

  Defined as the time from the date of radical surgery to the first occurrence of disease recurrence, progression, or death from any cause. Patients without an event will be censored at the date of the last follow-up. Disease status is determined through radiological, pathological, or clinical assessment as documented during follow-up.

  From the date of radical surgery to the date of disease recurrence, progression, death, or last follow-up, up to 5 years.

Secondary Outcomes (12)

• Postoperative Complications Incidence (Clavien- Dindo ≥ III)

  Within 30 days after surgery

• Treatment-Related Adverse Events (TRAEs) Incidence (CTCAE Grade ≥ 3)

  From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).

• Immune-Related Adverse Events (irAEs) Incidence

  From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).

• Progression-Free Survival (PFS)

  From the start of neoadjuvant immunotherapy to the date of disease progression, death, or last follow-up, up to 5 years.

• Overall Survival (OS)

  From the date of treatment initiation to death from any cause or last follow-up, up to 5 years

Interventions

neoadjuvant immunotherapy DRUG

Patients in the cohort received neoadjuvant immune checkpoint inhibitors (ICIs), including PD-1/PD-L1 inhibitors, as part of routine clinical care. The specific regimens included monotherapy or combination with chemotherapy. The agents used may include nivolumab, camrelizumab, sintilimab, atezolizumab, or others. This is a retrospective observational study. All interventions (neoadjuvant immunotherapy ± chemotherapy, surgery, or other treatments) were determined by treating physicians as part of standard care. The study aims to evaluate perioperative and survival outcomes across different treatment paths in real-world clinical settings.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include real-world patients diagnosed with stage IA-IIIC non-small cell lung cancer (NSCLC) who received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy). According to surgical evaluation, patients eligible for inclusion were assessed as either resectable or potentially resectable before treatment. Subsequent treatment following the neoadjuvant therapy may include surgical resection, radiotherapy, or non-localized therapy.

You may qualify if:

• Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations;
• Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment;
• Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy);
• Assessed as resectable or potentially resectable by surgical experts prior to treatment.

You may not qualify if:

• Confirmed M1 disease;
• History of previous lung malignancy or other metastatic malignant tumors;
• Participation in other randomized controlled trials involving neoadjuvant treatment;
• Significant missing clinical data.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (4)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Inner Mongolia Hospital of Peking University Cancer Hospital

Hohhot, Inner Mongolia, China

RECRUITING

The Third Affliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nan Wu, MD

CONTACT

0086-10-88196569; nanwu@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: December 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (4)