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Study protocol for the HARMONY study

Investigating treatment response and immune profile in association with pattern identification in NSCLC patients scheduled for immune checkpoint inhibitor monotherapy (HARMONY study): A protocol for a prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005173
Enrollment
200
Registered
2020-06-26
Start date
2020-08-28
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

None listed

Interventions

None listed

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with stage IIIB, IIIC, IV (TNM 8th edition) non-small cell lung cancer 2. Patients scheduled to be treated for immune checkpoint inhibitor (Pembrolizumab, Atezolizumab) monotherapy for secondary or higher line therapy after platinum-based primary therapy has been failed 3. Patients over 6 months survival expected 4. Patients with ECOG scale (ECOG-PS) 0-2 5. Patients who voluntarily participate to this clinical study with written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients having active brain metastases with clinically significant neurological symptoms or signs 2. Patients diagnosed with other malignancies within 5 years which may influence non-small cell lung cancer 3. Patients having autoimmune disease 4. Pregnant woman or lactating woman 5. Patients considered to be unsuitable to participate in this study by the investigators

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)

Secondary

MeasureTime frame
Overall Response Rate (ORR);Complete Response (CR) rate;Overall Survival (OS);Time To Response (TTR);Time to Tumor Progression (TTP);European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core questionnaire (EORTC QLQ-C30);European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung cancer 13 (EORTC QLQ-LC13);Adverse events;Immune assessment test (Blood)

Countries

Korea, Republic of

Contacts

Public ContactMi-kyung Jeong

Korea Institute of Oriental Medicine

oiny2000@kiom.re.kr+82-42-868-9475

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 11, 2026