Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164574
• Other study ID #: ImmEGFR
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 627
• Est. completion date: November 29, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Survival analysis
Immunotheray responses and long-term survival were evaluated in classical and other EGFR-mutant lung adenocarcinomas

Locations

Country	Name	City	State
China	Chaoqiang Deng	Shanghai	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Haiquan Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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