Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
North East Japan Study Group (NEJSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Pathologically diagnosed NSCLC. (2) Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC. (3) Subjects meet the diagnostic criteria for cachexia (body weight loss >= 5 % within the last 6 months). (4) Subjects have anorexia and 2 or more of the following (i) to (iii): (i) have fatigue or malaise, (ii) have reduced overall muscular strength, (iii) have more than 1 of the following conditions: CRP > 0.5 mg/dL, Hb < 12 g/dL, Alb < 3.2 g/dL. (5) No prior systemic therapy (including in cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitor) for advanced NSCLC. Subjects who received prior adjuvant and/or neo-adjuvant therapies are eligible. (6) Subjects scheduled to receive systemic therapy (cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitor are all acceptable). (7) Patients scheduled to receive anamorelin within 7 days prior to systemic therapy. (8) ECOG PS of 0 to 2. (9) Aged 18 years or more. (10) Provided Informed Consent.
Exclusion criteria
Exclusion criteria: (1) Current use of corticosteroids. (2) Subjects scheduled to receive systemic therapy, but don't fit into cohorts 1, 2, or 3. (3) Subjects with a history of hypersensitivity to anamorelin (4) Subjects with congestive heart failure (5) Subjects with myocardial infarction or angina pectoris (6) Subjects with severe conduction system disorders (such as complete atrioventricular block) (7) Subjects receiving the following drugs: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products (8) Subjects with liver dysfunction of more than moderate severity (Child-Pugh class B or C) (9) Subjects with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormality of the gastrointestinal tract (10) Subjects who are unable to accurately complete the QOL questionnaire. (11) Subjects who are judged by the principal or sub-investigator to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinically relevant improvement in FAACT (A/CS) at 3 weeks after the start of first-line chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| FAACT (A/CS), Questionnaire for eating-related distress among patients with advanced cancer (QERD), FACT-G, ECOG PS, KPS, body weight, objective response rate, disease control rate, progression-free survival, overall survival, adverse events, Composite Clinical Response (defined as the proportion of patients with an increase in body weight of >= 5 % and an increase in FAACT 5IASS score of >= 2 points at 3 weeks after the start of first-line chemotherapy) | — |
Countries
Japan
Contacts
Public ContactKeita Miura
Juntendo University Shizuoka Hospital Department of Respiratory Medicine
Outcome results
None listed