Clinical trial NCT06926179: Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer
Official title: Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer: A Multicenter Real-World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer (NSCLC)
Neoadjuvant Immunotherapy
Radiotherapy
Lung Surgery
Keywords: lung cancer
neoadjuvant immunotherapy
real-world study
radiotherapy
thoracic surgery
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: Lung cancer is the leading cause of cancer-related deaths in both China and the world. In recent years, neoadjuvant immunotherapy has achieved breakthrough advancements in the treatment of non-small cell lung cancer (NSCLC). Evidence from multiple Phase III randomized controlled trials (RCTs), such as CheckMate 816, KEYNOTE-671, and AEGEAN, has demonstrated clear benefits of this therapy in improving survival. However, these studies exhibited several limitations: first, stringent selection criteria resulting in limited heterogeneity among participants challenge the generalizability of their conclusions; Second, some studies and clinical observations have preliminarily suggested that neoadjuvant immunotherapy may increase technical surgical difficulty; however, large-sample, real-world data on its perioperative safety remain limited; third, clinical practice involves numerous borderline resectable and unresectable cases, leading to highly complex treatment decisions (such as timing of surgical intervention after conversion therapy, radiotherapy strategies, etc.), with none of the existing guidelines reach clear consensus.

This study employs a multicenter real-world design, establishing a retrospective cohort covering from neoadjuvant/induction therapy period to the surveillance period. It evaluates the safety, efficacy, and survival outcomes of neoadjuvant/induction immunotherapy across diverse treatment strategies including both surgery and radiotherapy, providing real-world evidence to inform clinical decision-making.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Technical Dissection Difficulty (TDD) Rate
timeFrame: During the radical surgery (Day 0 of surgery)
measure: Disease-Free Survival (DFS)
timeFrame: From the date of radical surgery to the date of disease recurrence, progression, death, or last follow-up, up to 5 years.
Secondary outcomes:
measure: Postoperative Complications Incidence (Clavien- Dindo ≥ III)
timeFrame: Within 30 days after surgery
measure: Treatment-Related Adverse Events (TRAEs) Incidence (CTCAE Grade ≥ 3)
timeFrame: From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).
measure: Immune-Related Adverse Events (irAEs) Incidence
timeFrame: From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).
measure: Progression-Free Survival (PFS)
timeFrame: From the start of neoadjuvant immunotherapy to the date of disease progression, death, or last follow-up, up to 5 years.
measure: Overall Survival (OS)
timeFrame: From the date of treatment initiation to death from any cause or last follow-up, up to 5 years
measure: Conversion Rate to Thoracotomy
timeFrame: During the radical surgery (Day 0)
measure: Operative Time (minutes)
timeFrame: During the radical surgery (Day 0)
measure: pathologic Complete Response (pCR) Rate
timeFrame: At the time of postoperative pathological assessment
measure: Major Pathologic Response (MPR) Rate
timeFrame: At the time of postoperative pathological assessment
measure: Number of Dissected Lymph Nodes (N1, N2)
timeFrame: During radical surgery (Day 0)
measure: Number of Dissected Lymph Node Stations (N1, N2)
timeFrame: During radical surgery (Day 0)
measure: Reduction Rate of Surgical Resection Extent
timeFrame: During the radical surgery (Day 0 of surgery)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Hohhot
country: China
facility: Inner Mongolia Hospital of Peking University Cancer Hospital
state: Inner Mongolia
city: Kunming
country: China
facility: The Third Affliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: