Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Non-Small Cell Lung Cancer Clinical Trial

— NeoR-World  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974007
• Other study ID #: 22/093-3294
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jie He, Dr.
• Phone: 010-87788863
• Email: prof.jiehe[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 1, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Neoadjuvant immunochemotherapy
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
• Neoadjuvant chemotherapy
Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Pathological Complete Response (pCR)	defined as 0% of viable tumor cells in primary tumor and lymph nodes	Within 2 weeks after surgery
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Major Pathological Response (MPR)	defined as =10% of viable tumor cells	Within 2 weeks after surgery
Secondary	Patterns of Relapse	Relapse was defined as disease recurrence at any site.	Within 5 years after surgery