Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Chemoimmunotherapy in Stage IIIA- N2IIIB Non-small Cell Lung Cancer

NCT06394427

Non-small Cell Lung Cancer Stage ⅢA Non-small Cell Lung Cancer Stage IIIB

NOT_YET_RECRUITING

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)

NCT06926790

Lung Cancer - Non Small Cell

RECRUITING PHASE2

Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment

NCT06751901

Advanced NSCLC

RECRUITING PHASE2

The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China

NCT04286841

Immunotherapy Lung Cancer

RECRUITING

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT06734702

Neoadjuvant Therapy Concurrent Chemoradiotherapy Immunotherapy +1 more

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resectable stage I-III NSCLC

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.

Neoadjuvant immunochemotherapy

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Neoadjuvant chemotherapy

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neoadjuvant immunotherapy Neoadjuvant platinum-based doublet chemotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes