GAIA-102 treatment for advanced non-small cell lung cancer
Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
This study is testing a new treatment called GAIA-102, alone and with another drug, to see if it can help people with advanced non-small cell lung cancer feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | GAIA BioMedicine Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 3 sites (Fukuoka-shi, Fukuoka and 2 other locations) |
| Trial ID | NCT05207371 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of GAIA-102, both alone and in combination with pembrolizumab, for patients with advanced or relapsed non-small cell lung cancer (NSCLC). The study is divided into two phases: Phase I focuses on determining the maximum tolerated dose and safety profile, while Phase II assesses the treatment's effectiveness at the recommended dose. Patients will be monitored for safety and response to treatment over multiple cycles.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with confirmed NSCLC and an ECOG performance status of 0-1.
Not a fit: Patients with active autoimmune diseases or those who have received allogeneic hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC.
How similar studies have performed: Other studies have shown promise in using cell therapies and immune checkpoint inhibitors for NSCLC, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fukuoka-shi, Fukuoka and 2 other locations
- Kyushu University Hospital — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Kitakyushu Municipal Medical Center — Kitakyushu, Fukuoka, Japan (Recruiting)
- Kurume University Hospital — Kurume, Fukuoka, Japan (Recruiting)
Study contacts
- Study coordinator: Masayoshi Tashiro, master
- Email: mtashiro@gaia-biomed.com
- Phone: +81-92-642-4708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.