Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Study Overview
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Brief Summary
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Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.

Detailed Description
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Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy. To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.

Official Title
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Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Neoadjuvant immunochemotherapy
* Drug: Neoadjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytological or histological diagnosis of non-small cell lung cancer Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery; Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition); No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment; ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery; At least one measurable lesion (RECIST v1.1); Age >= 18 years old and <= 85 years old; Be able to abide by the visits and related procedures stipulated in the program. Exclusion Criteria: Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown. Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resectable stage I-III NSCLC<br>Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist. | Drug: Neoadjuvant immunochemotherapy<br>* Patients with operable stage I-III NSCLC who have previously undergone platinum drugs and immune checkpoint inhibitors(Anti PD-1) and then undergone radical surgery<br>* Other names: Neoadjuvant immunotherapy;Drug: Neoadjuvant chemotherapy<br>* Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery<br>* Other names: Neoadjuvant platinum-based doublet chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival(DFS) | Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence). | DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years. | 
| Pathological Complete Response (pCR) | defined as 0% of viable tumor cells in primary tumor and lymph nodes | Within 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS (overall survival) | OS is defined as the time from surgery tiem until death from any cause. | From date of surgery until date of death due to any cause, up to approximately 5 years. | 
| Overall Survival (overall survival) Rate | OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis. | From date of surgery until date of death due to any cause. Assessed at 1 years. | 
| Overall Survival (overall survival) Rate | OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis. | From date of surgery until date of death due to any cause. Assessed at 2 years. | 
| Overall Survival (overall survival) Rate | OS is defined as the time from surgery tiem until death from any cause, estimated from a Kaplan Meier plot of OS at the time of the primary analysis. | From date of surgery until date of death due to any cause. Assessed at 5 years. | 
| EFS (event-free survival) | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | Up to 5 years after first therapy. | 
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 1 years after neoadjuvant. | 
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 2 years after neoadjuvant. | 
| Event Free Survival (event-free survival) Rate | EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. | From date of first received neoadjuvant therapy to 5 years after neoadjuvant. | 
| Major Pathological Response (MPR) | defined as ≤10% of viable tumor cells | Within 2 weeks after surgery | 
| Patterns of Relapse | Relapse was defined as disease recurrence at any site. | Within 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Neoadjuvant immunochemotherapy, Neoadjuvant chemotherapy, Real world study