Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: Within 2 weeks after surgery

Secondary Outcomes

OS (overall survival)

OS is defined as the time from surgery tiem until death from any cause.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.

Major Pathological Response (MPR)

defined as ≤10% of viable tumor cells

Time frame: Within 2 weeks after surgery

Patterns of Relapse

Relapse was defined as disease recurrence at any site.

Time frame: Within 5 years after surgery

Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts