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

NCT04777175 | Recruiting

• 1 other identifier: IRMLC
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (6)

KRAS mutation

patients carry with KRAS mutation

Drug: immunity therapy

ALK fusion

patients carry with ALK fusion

Drug: immunity therapy

ERBB2 mutation

patients carry with ERBB2 mutation

Drug: immunity therapy

MET skipping/amplication

patients carry with MET skipping/amplication

Drug: immunity therapy

RET fusion

patients carry with RET fusion

Drug: immunity therapy

BRAF mutation

patients carry with BRAF mutation

Drug: immunity therapy

Interventions

immunity therapy DRUG

The patient receives immunotherapy

ALK fusion; BRAF mutation; ERBB2 mutation; KRAS mutation; MET skipping/amplication; RET fusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• The patient is diagnosed with small cell lung cancer

Sponsors & Collaborators

• Yongchang Zhang: lead
• Hunan Province Tumor Hospital: collaborator

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immunization, Passive

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 2, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 12, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)