Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Survival analysis

• Study Type: Observational
• Enrollment (Actual): 627

Contacts and Locations

Study Locations

• China
  • Please Select
    • Shanghai, Please Select, China, 200032
      • Chaoqiang Deng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survivals	Progression-free survivals were defined as the time from the initial treatment to the date of disease progression or death	5 years

Collaborators and Investigators

• Sponsor: Haiquan Chen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ImmEGFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No