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Trial Title:
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC
NCT ID:
NCT05974007
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents
Conditions: Keywords:
NSCLC
Neoadjuvant immunochemotherapy
Neoadjuvant chemotherapy
Real world study
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Neoadjuvant immunochemotherapy
Description:
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
Arm group label:
Resectable stage I-III NSCLC
Other name:
Neoadjuvant immunotherapy
Intervention type:
Drug
Intervention name:
Neoadjuvant chemotherapy
Description:
Patients with operable stage I-III NSCLC who have previously undergone platinum-based
chemotherapy regimens and then undergone radical surgery
Arm group label:
Resectable stage I-III NSCLC
Other name:
Neoadjuvant platinum-based doublet chemotherapy
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.
Criteria for eligibility:
Study pop:
Stage I-III NSCLC patients undergo neoadjuvant treatment.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie He, Dr.
Phone:
010-87788863
Email:
prof.jiehe@gmail.com
Start date:
January 1, 2022
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05974007
