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The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are:
The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant immunotherapy | Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. |
| |
| Other neoadjuvant treatment | Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant immunotherapy | Drug | Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | defined as 0% of viable tumor cells in primary tumor and lymph nodes | Within 15 days after surgery |
| 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 date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from surgery time until death from any cause. | From date of surgery until date of death due to any cause, up to approximately 10 years. |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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NSCLC patients receiving neoadjuvant immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shugeng Gao, MD | Contact | 8610-87788177 | gaoshugeng@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shugeng Gao, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shugeng Gao | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| Other drugs for neoadjuvant treatment | Drug | Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC. |
|
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EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
| EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years. |
| Major Pathological Response (MPR) | defined as ≤10% of viable tumor cells | Within 15 days after surgery |
| Relapse Patterns | Relapse was defined as disease recurrence at any site. | Within 10 years after surgery |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |