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OpenTrials
Completed

NCT Number: NCT06164574

Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chaoqiang Deng

Shanghai, Please Select, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

-

Treatment and study plan

Survival analysis

Other

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

Primary outcomes

  1. Tumor response

    Time frame: 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

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

Secondary outcomes

  1. Progression-free survivals

    Time frame: 5 years

    Progression-free survivals were defined as the time from the initial treatment to the date of disease progression or death

Sponsors and collaborators

Lead sponsor

Haiquan Chen

Other

Registry information

Official study title

Distinct Survivals and Optimal Combination of Immunotherapy Plus Immunophenotype in Uncommon and 20ins EGFR-mut Lung Adenocarcinoma: a Retrospective Multi-center Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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