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Search / Trial NCT05207371

Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Launched by GAIA BIOMEDICINE INC. · Jan 13, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GAIA-102 for patients with advanced or relapsed non-small cell lung cancer (NSCLC), which is a common type of lung cancer. The trial is divided into two parts. In the first part, researchers want to find out if GAIA-102 is safe to use on its own or together with another medication called pembrolizumab. They will also determine the best dose of GAIA-102 to use in the next part of the trial. The second part will focus on how effective and safe GAIA-102 is at that recommended dose.

To participate in this trial, patients must be at least 20 years old and have been diagnosed with NSCLC. They should also have a good performance status, meaning they are able to perform daily activities without much difficulty. However, patients with certain conditions, such as active brain metastases or autoimmune diseases, may not be eligible. If you join this trial, you will be closely monitored by healthcare professionals to ensure your safety and to track how well the treatment works. This trial is currently recruiting participants, so if you're interested, you can speak with your doctor for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients who have been confirmed to have NSCLC by histological or cytological examination
  • 2. Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent
  • 3. Patients aged 20 years or older at the time of obtaining consent
  • Exclusion Criteria:
  • 1. Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible.
  • 2. Patients diagnosed with cancerous meningitis
  • 3. Patients who received allogeneic hematopoietic stem cell transplantation
  • 4. Patients with active autoimmune disease

About Gaia Biomedicine Inc.

Gaia Biomedicine Inc. is a pioneering biotechnology company dedicated to advancing innovative therapeutic solutions for complex medical conditions. With a strong emphasis on research and development, Gaia Biomedicine leverages cutting-edge technologies and a team of experienced professionals to create targeted treatment modalities that enhance patient outcomes. The company is committed to rigorous clinical trials and robust regulatory compliance, ensuring that its products meet the highest standards of safety and efficacy. Through collaboration with leading research institutions and healthcare providers, Gaia Biomedicine aims to transform the landscape of modern medicine and improve the quality of life for patients worldwide.

Locations

Kurume, Fukuoka, Japan

Fukuoka Shi, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Patients applied

0 patients applied

Trial Officials

Yoshikazu Yonemitsu, MD, PhD

Study Director

Graduate School of Pharmaceutical Sciences, Kyushu University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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