Study protocol for the HARMONY study
- Conditions
- Neoplasms
- Registration Number
- KCT0005173
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method 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)