Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers

NCT06164574 | Completed

• 1 other identifier: ImmEGFR
• Study Type: observational
• Target: 627
• Locations: 1 country
• Sites: 1

Brief Summary

Immunotherapy effectiveness and optimal combination strategy in lung cancers with EGFR uncommon and 20ins mutations was unclear. Based on 627 lung adenocarcinoma patients harboring EGFR mutations and receiving immunotherapy, we reported that patients with EGFR uncommon mutations had better response to immunotherapy, than EGFR 19del/L858R or 20in mutations. Immunotherapy monotherapy or plus chemotherapy was identified as better combination strategy for EGFR uncommon or 20ins mutations, respectively. Higher tumor mutation burden, more M1 macrophage, less Tregs and M2 macrophages infiltration, but not PD-L1 expression was found to be associated with EGFR uncommon mutations, compared to EGFR 19del/L858R or 20in mutations. These findings revealed diverse response and optimal combination strategy of lung adenocarcinoma patients harboring EGFR mutation subtypes, promoting rethinking about current immunotherapy application and prolonging survivals of them.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Partial response, disease progression, and stable disease were defined according to the RECIST v1.1

  From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (1)

• Progression-free survivals

  5 years

Interventions

Survival analysis OTHER

Immunotheray responses and long-term survival were evaluated in classical and other EGFR-mutant lung adenocarcinomas

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

EGFR-mutant LUAD patients receiving anti-PD-(L)1 therapies

You may qualify if:

• age≥18 years,
• advanced or recurrent LUAD confirmed by pathology,
• harboring EGFR mutations confirmed by super amplification refractory mutation system (super-ARMS) or next-generation sequencing (NGS),
• receiving anti-PD-(L)1 antibody therapy at least once,
• Radiologically evaluable according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)

Sponsors & Collaborators

• Haiquan Chen: lead

Study Sites (1)

Chaoqiang Deng

Shanghai, Please Select, 200032, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Survival Analysis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 11, 2023
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 29, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

CN (1)