Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC (NeoR-World)

August 1, 2023 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Stage I-III NSCLC patients undergo neoadjuvant treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • Neoadjuvant immunotherapy
Drug: Neoadjuvant chemotherapy
Patients with operable stage I-III NSCLC who have previously undergone platinum-based chemotherapy regimens and then undergone radical surgery
Other Names:
  • Neoadjuvant platinum-based doublet chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival(DFS)
Time Frame: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
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.
Pathological Complete Response (pCR)
Time Frame: Within 2 weeks after surgery
defined as 0% of viable tumor cells in primary tumor and lymph nodes
Within 2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS (overall survival)
Time Frame: From date of surgery until date of death due to any cause, up to approximately 5 years.
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.
Overall Survival (overall survival) Rate
Time Frame: From date of surgery until date of death due to any cause. Assessed at 1 years.
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.
Overall Survival (overall survival) Rate
Time Frame: From date of surgery until date of death due to any cause. Assessed at 2 years.
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.
Overall Survival (overall survival) Rate
Time Frame: From date of surgery until date of death due to any cause. Assessed at 5 years.
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.
EFS (event-free survival)
Time Frame: Up to 5 years after first therapy.
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.
Event Free Survival (event-free survival) Rate
Time Frame: From date of first received neoadjuvant therapy to 1 years after neoadjuvant.
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.
Event Free Survival (event-free survival) Rate
Time Frame: From date of first received neoadjuvant therapy to 2 years after neoadjuvant.
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.
Event Free Survival (event-free survival) Rate
Time Frame: From date of first received neoadjuvant therapy to 5 years after neoadjuvant.
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.
Major Pathological Response (MPR)
Time Frame: Within 2 weeks after surgery
defined as ≤10% of viable tumor cells
Within 2 weeks after surgery
Patterns of Relapse
Time Frame: Within 5 years after surgery
Relapse was defined as disease recurrence at any site.
Within 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Jie He, Dr., Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/093-3294

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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