Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

NCT06317558 | Recruiting FDA Drug

• 1 other identifier: 22/492-3694
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?
• How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• Overall survival (OS)

  From date of surgery until date of death due to any cause, up to approximately 10 years.

• Event-free survival (EFS)

  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)

  Within 15 days after surgery

• Relapse Patterns

  Within 10 years after surgery

Study Arms (2)

Neoadjuvant immunotherapy

Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Drug: Neoadjuvant immunotherapy

Other neoadjuvant treatment

Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Drug: Other drugs for neoadjuvant treatment

Interventions

Neoadjuvant immunotherapy DRUG

Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.

Also known as: Immune checkpoint inhibitors

Neoadjuvant immunotherapy

Other drugs for neoadjuvant treatment DRUG

Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Also known as: Other drugs

Other neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients receiving neoadjuvant immunotherapy.

You may qualify if:

• Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
• Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
• No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
• Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
• At least one measurable lesion (RECIST v1.1).

You may not qualify if:

• Patients included in unblinded clinical trials or anti-tumor drug intervention.
• Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Shugeng Gao

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Combined Modality Therapy; Therapeutics

Study Officials

• Shugeng Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shugeng Gao, MD

CONTACT

8610-87788177; gaoshugeng@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2034
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

CN (1)