Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

NCT05974007 | Recruiting FDA Drug

• 1 other identifier: 22/093-3294
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Neoadjuvant immunochemotherapy; Neoadjuvant chemotherapy; Real world study

Outcome Measures

Primary Outcomes (2)

• 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 appearance of metastasis, up to approximately 5 years.

• Pathological Complete Response (pCR)

  defined as 0% of viable tumor cells in primary tumor and lymph nodes

  Within 2 weeks after surgery

Secondary Outcomes (10)

• OS (overall survival)

  From date of surgery until date of death due to any cause, up to approximately 5 years.

• Overall Survival (overall survival) Rate

  From date of surgery until date of death due to any cause. Assessed at 1 years.

• Overall Survival (overall survival) Rate

  From date of surgery until date of death due to any cause. Assessed at 2 years.

• Overall Survival (overall survival) Rate

  From date of surgery until date of death due to any cause. Assessed at 5 years.

• EFS (event-free survival)

  Up to 5 years after first therapy.

Study Arms (1)

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; Drug: Neoadjuvant chemotherapy

Interventions

Neoadjuvant immunochemotherapy 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

Also known as: Neoadjuvant immunotherapy

Resectable stage I-III NSCLC

Neoadjuvant chemotherapy DRUG

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

Also known as: Neoadjuvant platinum-based doublet chemotherapy

Resectable stage I-III NSCLC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stage I-III NSCLC patients undergo neoadjuvant treatment.

You may qualify if:

• Cytological or histological diagnosis of non-small cell lung cancer
• Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
• Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
• No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
• ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
• At least one measurable lesion (RECIST v1.1);
• Age \>= 18 years old and \<= 85 years old;
• Be able to abide by the visits and related procedures stipulated in the program.

You may not qualify if:

• Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
• Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

Sponsors & Collaborators

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

Study Sites (1)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Jie He, Dr.

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Jie He, Dr.

CONTACT

010-87788863; prof.jiehe@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 3, 2023
• Study Start: January 1, 2022
• Primary Completion: August 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 3, 2023

Record last verified: 2023-05

Locations

CN (1)