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

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05637580
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Actual Duration (Months): 37.4
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer; Immunotherapy; Chemotherapy; Tumour, Residual	Drug: Timing of drug administration

Study Design

• Study Type: Observational
• Actual Enrollment: 110 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer
• Actual Study Start Date: May 20, 2019
• Actual Primary Completion Date: Jul 1, 2022
• Actual Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
combined well responder Both primary tumor and nodal response achieve major pathological response (MPR).	Drug: Timing of drug administration; The effect of drug administration timing on tumor and lymph node responses was observed.
poor responder Primary tumor or/and nodal response can not achieve MPR.	Drug: Timing of drug administration; The effect of drug administration timing on tumor and lymph node responses was observed.

Outcome Measures

Primary Outcome Measures

1. Event-free survival [At least one year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.

• early-stage NSCLC patients who were initially unresectable.

• 18 years of age or older.

• Karnofsky performance status (KPS) score of 100 or 90.

Exclusion Criteria:

• Patients with stage IV NSCLC

• Patients with known ALK translocations or EGFR mutations.

• Karnofsky performance status (KPS) score <90.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Guangdong Provincial People's Hospital

Investigators

• Study Director: Guibin Qiao, MD, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT05637580
• Other Study ID Numbers: LUNGTN
• First Posted: Dec 5, 2022
• Last Update Posted: Dec 5, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual

Study Results

No Results Posted as of Dec 5, 2022