Phase I / II Clinical Trial of GAIA-102 for advanced and relapse NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2073210080

Enrollment

Registered

2021-10-19

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced and relapse NSCLC

Interventions

GAIA-102 is administered as a single agent or combination with Pembrolizumab.

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Phase I part - Presence or absence of DLT expression - Frequency and severity of adverse events Phase II part - Objective Response Rate	—

Secondary

Measure	Time frame
Phase I part - Objective Response Rate and Disease Control Rate - Progression-free Survival - Overall Survival - Pharmacokinetics of GAIA-102 - Biomarker Phase II part - Disease Control Rate - Progression-free Survival - Overall Survival - Biomarker	—

Contacts

Public ContactMasayoshi Tashiro

GAIA BioMedicine Inc.

mtashiro@gaia-biomed.com+81-92-642-4708

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026