Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

NCT05637580 | Completed DMC

• 1 other identifier: LUNGTN
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.

Conditions

Non Small Cell Lung Cancer; Immunotherapy; Chemotherapy; Tumour, Residual

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.

  At least one year

Study Arms (2)

combined well responder

Both primary tumor and nodal response achieve major pathological response (MPR).

Drug: Timing of drug administration

poor responder

Primary tumor or/and nodal response can not achieve MPR.

Drug: Timing of drug administration

Interventions

Timing of drug administration DRUG

The effect of drug administration timing on tumor and lymph node responses was observed.

combined well responder; poor responder

Eligibility Criteria

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

Study Population

Patients with stage II-III NSCLC who received neoadjuvant immunochemotherapy (time) in Guangdong Provincial People's Hospital were eligible for this study. We also included early-stage NSCLC patients who were unsuitable or unable to tolerate surgery after first evaluation. Eligible patients were 18 years of age or older, had a karnofsky performance status (KPS) score of 100 or 90 (on a scale from 0 to 100 with higher score indicating better ability to carry out daily activities). Patients with distant tumor metastasis or with known ALK translocations or EGFR mutations were excluded.

You may qualify if:

• Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
• early-stage NSCLC patients who were initially unresectable.
• years of age or older.
• Karnofsky performance status (KPS) score of 100 or 90.

You may not qualify if:

• Patients with stage IV NSCLC
• Patients with known ALK translocations or EGFR mutations.
• Karnofsky performance status (KPS) score \<90.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guibin Qiao, MD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: May 20, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-11

Locations

CN (1)