SPIRAL-ANA study

JRCT ID: jRCT1071210053

Registered date:24/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 08/09/2021
• Target sample size: 127
• Study type: Observational

Outcome(s)

• Primary Outcome: Progression free survival (PFS)

Secondary Outcome

Safety of combined immunochemotherapy in non-small cell lung cancer (NSCLC) patients treated with anamorelin
Best overall response (BOR), time to treatment failure (TTF), and overall survival(OS) for combined immunochemotherapy in NSCLC patients treated with anamorelin. BOR, TTF, PFS, and OS with and without programmed death-ligand-1 expression. Changes in body weight and ECOG-PS,QOL-ACD score at 3, 12, and 24 weeks after initiation of anamorelin. Anamorelin continuation rate at 12 weeks after treatment initiation.
Prevalence of cancer cachexia at 12 and 24 weeks after initiation of anamorelin.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 20 or older at the time of informed consent).
2) Patients who are to receive combined immunochemotherapy and who are to receive anamorelin 7 days prior to and on the same day as the first dose.
3) Patients with histologically or cytologically confirmed non-small cell lung cancer.
4) Patients with Stage III/IV or postoperative recurrence who are not eligible for radical radiation therapy or resection.
5) Patients with positive driver gene should be treated with kinase inhibitors.
6) Patients who have not been treated with cell-killing anticancer agents for advanced stage or postoperative recurrence lung cancer. However, preoperative and postoperative adjuvant chemotherapy is acceptable.
7) Patients who meet the criteria for administration of anamorelin.
Patients with weight loss of 5% or more and anorexia within 6 months, and at least 2 of the following (1) to (3)
(1) Fatigue or malaise
(2) General muscle weakness
(3) CRP level >0.5 mg/dl, albumin level <3.2 g/dL, hemoglobin level <12 g/dl
8) Patients with at least one measurable lesion in accordance with RECISTv1.1 criteria.
9) Patients with a Performance Status (ECOG) of 0-2.
10) Patients who are expected to survive for at least 3 months.
11) Patients for whom written consent has been obtained from the patient.

Exclude criteria

1) Patients with contraindications to anamorelin administration.
(1) Patients with congestive heart failure
(2) Patients with myocardial infarction or angina pectoris
(3) Patients with severe stimulation conduction system disorder (e.g. complete atrioventricular block)
(4) Patients receiving the following drugs: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products.
(5) Patients with moderate or severe hepatic dysfunction (Child-Pugh classification B and C)
(6) Patients with a history of hypersensitivity to any component of anamorelin.
(7) Patients with difficulty in oral intake of food due to organic abnormalities of the gastrointestinal tract such as gastrointestinal obstruction.
2) Patients with poorly controlled diabetes mellitus.
3) Patients with intractable nausea and vomiting, chronic gastrointestinal disorders, inability to swallow preparations, or a history of gastrectomy or other procedures that may significantly affect the absorption of anamorelin.
4) Other patients who are deemed inappropriate for this study by the physician in charge or others.

Related Information

• Primary Sponsor: Uchino Junji
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.