Phase I / II Clinical Trial of GAIA-102 for advanced and relapse NSCLC
Phase 1
Recruiting
- Conditions
- advanced and relapse NSCLCCarcinoma, Non-Small-Cell Lung
- Registration Number
- JPRN-jRCT2073210080
- Lead Sponsor
- Okamoto Isamu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I part<br>- Presence or absence of DLT expression<br>- Frequency and severity of adverse events<br>Phase II part<br>- Objective Response Rate
- Secondary Outcome Measures
Name Time Method Phase I part<br>- Objective Response Rate and Disease Control Rate<br>- Progression-free Survival<br>- Overall Survival<br>- Pharmacokinetics of GAIA-102<br>- Biomarker <br>Phase II part<br>- Disease Control Rate<br>- Progression-free Survival<br>- Overall Survival<br>- Biomarker