Clinical trial NCT05974007: Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC
Official title: Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Neoadjuvant immunochemotherapy
Neoadjuvant chemotherapy
Real world study
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage I-III NSCLC patients undergo neoadjuvant treatment.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Cytological or histological diagnosis of non-small cell lung cancer
2. Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
3. Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
4. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
5. ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
6. At least one measurable lesion (RECIST v1.1);
7. Age \>= 18 years old and \<= 85 years old;
8. Be able to abide by the visits and related procedures stipulated in the program.

Exclusion Criteria:

1. Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
2. Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

Primary outcomes:
measure: Disease-free survival(DFS)
timeFrame: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
measure: Pathological Complete Response (pCR)
timeFrame: Within 2 weeks after surgery
Secondary outcomes:
measure: OS (overall survival)
timeFrame: From date of surgery until date of death due to any cause, up to approximately 5 years.
measure: Overall Survival (overall survival) Rate
timeFrame: From date of surgery until date of death due to any cause. Assessed at 1 years.
measure: Overall Survival (overall survival) Rate
timeFrame: From date of surgery until date of death due to any cause. Assessed at 2 years.
measure: Overall Survival (overall survival) Rate
timeFrame: From date of surgery until date of death due to any cause. Assessed at 5 years.
measure: EFS (event-free survival)
timeFrame: Up to 5 years after first therapy.
measure: Event Free Survival (event-free survival) Rate
timeFrame: From date of first received neoadjuvant therapy to 1 years after neoadjuvant.
measure: Event Free Survival (event-free survival) Rate
timeFrame: From date of first received neoadjuvant therapy to 2 years after neoadjuvant.
measure: Event Free Survival (event-free survival) Rate
timeFrame: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.
measure: Major Pathological Response (MPR)
timeFrame: Within 2 weeks after surgery
measure: Patterns of Relapse
timeFrame: Within 5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Jie He, Dr.
role: STUDY_CHAIR
References: