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Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Recruiting
18-85 years
All
Phase N/A

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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.

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

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.

Study details
    Non-Small Cell Lung Cancer

NCT05974007

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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