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A prospective observational study of the effect of ANamorelin Administration on combined immunochemotherapy in patients with non-small cell lung cancer (SPIRAL-ANA study)

SPIRAL-ANA study (SPIRAL-ANA study)

123

One hundred and twenty-three patients with advanced or postoperative recurrent non-small cell lung cancer with cancer cachexia, aged 20 years or older, who were to receive chemoimmunotherapy with anamorelin, were enrolled. This was considered the total enrollment. Of these, 5 patients were excluded from the safety analysis population due to case enrollment after treatment initiation (2 patients) and discontinuation before treatment initiation (3 patients). In addition, 4 patients were excluded from the largest analysis population because they started protocol treatment with anamorelin and pembrolizumab alone (1 patient), started anamorelin 12 days before the first dose of chemoimmunotherapy (1 patient), or did not have measurable disease according to RECISTv1.1 criteria (2 patients). The safety analysis population (FAS) was therefore excluded from the analysis. Based on the above, the safety analysis population was 118 patients, and the efficacy analysis population was 114 patients.

123 patients were enrolled from August 4, 2021 to January 31, 2024, and of these, 118 patients were given protocol treatment.

[Adverse events occurring in more than 80% of all Grades] Anemia 111/118=95.7%, Hypoalbuminemia 115/118=99.1%, Fatigue 99/118=84.6%, Malaise 103/118=87.3% [Adverse events occurring in more than 20% of Grade 3 or higher] White blood cell decreased 24/116=20.7%,Neutrophil count decreased 37/116=31.9%

[Primary endpoint] The progression-free survival for patients treated with anamorelin was 6.2 months (95% CI: 4.6-7.7 months ), and the lower limit of the 95% CI for mPFS (4.6 months) could not exceed the threshold of 5.0 months, so this protocol treatment could not be considered effective. Therefore, this protocol treatment could not be judged to be effective. [Secondary endpoints] Safety in chemoimmunotherapy in patients treated with anamorelin: as described in the summary of adverse events. Best Outcome Response (BOR) for chemoimmunotherapy in patients treated with anamorelin : In this study, BOR is defined as the percentage of patients whose best overall response (response rate) is either CR or PR. The BOR for FAS was 66/114=57.9% (95%CI:48.7%-66.6%). Treatment success period (TTF) :The TTF for FAS was 4.2 months (95% confidence interval: 13.1-28.6 months). Overall Survival (OS) :The OS for FAS was 18.5 months (95% confidence interval: 13.1 - 28.6 months). BOR, TTF, PFS, and OS by PD-L1 expression status :The BOR for PD-L1 expression in patients with FAS was 51/82 pixels or 62.2% (95% confidence interval: 51.4% - 71.9%), TTF was 4.2 months (95% confidence interval: 3.7-5.4months), PFS was 5.7 months (4.4-7.5 months), and OS was 18.2 months (95 % confidence interval: 13.1-28.6 months) In the case of no PD-L1 expression, the BOR was 14/28 collateral 50.0% (95% CI: 32.6% -67.4%), TTF was 5.0 months (95% CI: 1.9-7.8months), PFS was 7.8 months (5.2-14.2months), and OS was not reached. (95% CI: 9 .6 months -NR). Weight and ECOG-PS and QOL-ACD scores at 3, 12, and 24 weeks after starting anamorelin: The mean weight for FAS was 54.3 kg before enrollment and 54.5 kg after 24 weeks, with an average increase of 0.2 kg after 24 weeks. The mean ECOG-PS was 1.1 before enrollment and 1.0 after 24 weeks, a decrease of 0.1. The mean Overall QOL-ACD score was 71.2 before enrollment and 72.4 after 24 weeks, an increase of 1.2. Anamorelin continuation rate at 12 weeks :Anamorelin continuation rate after 12 weeks was 62/114 offers (54.4%). Prevalence of cancer cachexia at 12 and 24 weeks. :The prevalence of cancer cachexia at 12 and 24 weeks was tabulated for FAS. Cases that did not meet the criteria for cachexia and lacked the information necessary to determine cachexia at each time point were excluded from the tally at each time point. The prevalence rate at 12 weeks, based on baseline, was 12/85=14.1% and at 24 weeks was 6/61=9.8%. The prevalence rate at 12 weeks, based on the highest weight at 6 months before enrollment, was 24/85=28.2%, and at 24 weeks, 11/61=18.0%

The study was designed to evaluate the efficacy and safety of chemoimmunotherapy with anamorelin in advanced or postoperative recurrent non-small cell lung cancer with cancer cachexia. The primary endpoint of progression-free survival was lower than originally expected, and the protocol treatment could not be considered effective.

June. 30, 2026

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCT1071210053

Uchino Junji

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho,Hirokoji-agaru, Kawaramachi, Kamigyo-ku, Kyoto

uchino@koto.kpu-m.ac.jp

Morimoto Kenji

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho,Hirokoji-agaru, Kawaramachi, Kamigyo-ku, Kyoto

+81-75-251-5513

m-kenji@koto.kpu-m.ac.jp

Complete

Aug. 24, 2021

Observational

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.

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.

Both

non-small cell lung cancer

non-small cell lung cancer

Progression free survival (PFS)

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.

+81-92-643-7171

Aug. 04, 2021

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