A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer

In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Therefore, we conducted this retrospective clinical study to explore the efficacy of immunotherapy for different rare mutations.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: immunity therapy

• Study Type: Observational
• Enrollment (Estimated): 186

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762321; Email: zhangyongchang@csu.edu.cn
      • Contact: Nong Yang, MD; Phone Number: +86 731 89762323; Email: yangnong0217@163.com
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762321; Email: zhangyongchang@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced non-small-cell lung cancer carrying KRAS, ALK, ERBB2, MET, RET, BRAF mutation.

Description

Inclusion Criteria:

• 1.Diagnosed as advanced non-small cell lung cancer
• 2.Confirmed as KARS, ALK, ERBB2, MET, RET, BRAF mutation

Exclusion Criteria:

• The patient is diagnosed with small cell lung cancer

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KRAS mutation; patients carry with KRAS mutation	Drug: immunity therapy; The patient receives immunotherapy
ALK fusion; patients carry with ALK fusion	Drug: immunity therapy; The patient receives immunotherapy
ERBB2 mutation; patients carry with ERBB2 mutation	Drug: immunity therapy; The patient receives immunotherapy
MET skipping/amplication; patients carry with MET skipping/amplication	Drug: immunity therapy; The patient receives immunotherapy
RET fusion; patients carry with RET fusion	Drug: immunity therapy; The patient receives immunotherapy
BRAF mutation; patients carry with BRAF mutation	Drug: immunity therapy; The patient receives immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	January 2021- January 2021 (1 year)

Collaborators and Investigators

• Sponsor: Yongchang Zhang
• Collaborators: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 12, 2025

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IRMLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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