Immunotherapy for Non-small Cell Lung Cancer Patients with Cancer Cachexia

A Phase II Study of Anamorelin and Ipilimumab plus Nivolumab in non-small cell lung cancer (NSCLC) patients with Cancer Cachexia - NEJ058A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047035

Enrollment

Registered

2022-03-01

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

non-small cell lung cancer

Interventions

1) Anamorelin daily 100mg p.o. 2) Ipilimumab 1mg/Kg div, once 6 weeks 3) Nivolumab 120mg/week div, biweekly or triweekly

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically non-small cell lung cancer (2) Negative for EGFR mutations and ALK mutations (3) Stage 3B, 3C, 4A, or 4B or post operative recurrence (4) ECOG performance status (PS) 0-1 (5) Cancer Cachexia (6) 20-79 years old (7) Adequate organ functions 1)Neutrophil count: more than 1,500/m3 2)Hb: more than 9.0g/dL 3)Platelet: more than 100,000/m3 4)AST: less than 2.5 folds of normal upper limit 5)ALT: less than 2.5 folds of normal upper limit 6)Total bilirubin: less than 1.5 folds of normal upper limit 7)Serum creatinine: less than 1.5mg/dL 8)SpO2: more than 95% (8) Life expectancy: more than 12 weeks (9) Obtained written informed consent

Exclusion criteria

Exclusion criteria: (1) Allergy for drugs used in this study (2) Congestive heart failure, myocardial infarction, complete AV block etc, QTc longer than 470msec (3) Contraindication drug for Anamorelin (4) Double cancer (5) Other cancer treatments such as cytotoxic drug, immunotherapy, biological drug, and hormone therapy (6) Apparent interstitial lung disease (ILD) diagnosed by Chest X-ray (7) Active B hepatitis (8) Primary immunodeficiency (9) Gastrointestinal obstruction, post total gastrectomy, active bowel inflammation such as Crohn disease and ulcerative colitis (10) Sever complications (11) Steroid treatment for more than 4 weeks (12) Autoimmune disease (13) Pregnancy and its possibilities (14) Post organ implantation (15) Other inappropriate conditions judged by doctors

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	—

Countries

Japan

Contacts

Public ContactHiromi Odagiri

NPO North East Japan Study Group Secretary of NEJSG

nejsg-dm@nejsg.jp048-778-9521

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026