Phase II Study of Anamorelin with Nutritional and Exercise Treatment for Cancer Cachexia (NEXTAC-III)

Randomized Phase II Study of Anamorelin Hydrochloride with Nutritional and Exercise Treatment for Cancer Cachexia among Elderly Patients with Advanced Non-small Cell Lung and Pancreatic Cancer (NEXTAC-III study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041210053

Enrollment

Registered

2021-08-17

Start date

2021-11-29

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

Elderly Patients with advanced non-small cell lung and pancreatic cancer

Interventions

1)Standard chemotherapy: Lung cancer: carboplatin + pemetrexed +-pembrolizumab, carboplatin + nab-paclitaxel +- pembrolizumab, pembrolizumab, or docetaxel Pancreatic cancer: Nanoliposomal irinotecan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age >= 65years and ECOG-PS 0 or 1 2)Histologically or cytologically proven advanced (locally advanced or metastatic) non-small cell lung or pancreatic cancer 3)Cancer cachexia with an indication of anamorelin hydrochloride 4)Scheduled new systemic chemotherapy (first-line in non-small cell lung cancer and second-line in pancreatic cancer) 5)More than three months of expected survival time 6)Written informed consent was obtained

Exclusion criteria

Exclusion criteria: 1)Having an indication for curative radiotherapy or surgery 2)Having a severe psychiatric disorder, an active infectious disease, unstable cardiopulmonary disease, uncontrolled diabetes mellitus, or severe liver dysfunction 3)Inability to ingest, digest, or absorb food or oral medications 4)Having symptomatic brain or bone metastases that prevented safe assessments or interventions 5)Contraindicated for anamorelin hydrochloride

Design outcomes

Primary

Measure	Time frame
The proportion of patients with a clinically meaningful reduction in 6-minute walking distance or unable to assess	—

Secondary

Measure	Time frame
1)Participation rate 2)Change in 6-minute walking distance 3)Change in global QOL score in EORTC-QLQ-C30 4)Change in FAACT anorexia score 5)Change in bodyweight 6)Change in skeletal muscle index 7)Disability-free survival 8)Overall survival 9)Safty 10)Compliance for anamorelin hydrochloride 11)The proportion of patients with a clinically meaningful reduction in 6-minute walking distance orunable to assess (whole registered population)	—

Measure

Time frame

1)Participation rate 2)Change in 6-minute walking distance 3)Change in global QOL score in EORTC-QLQ-C30 4)Change in FAACT anorexia score 5)Change in bodyweight 6)Change in skeletal muscle index 7)Disability-free survival 8)Overall survival 9)Safty 10)Compliance for anamorelin hydrochloride 11)The proportion of patients with a clinically meaningful reduction in 6-minute walking distance orunable to assess (whole registered population)

—

Contacts

Public ContactKoichi Takayama

University Hospital, Kyoto Prefectural University of Medicine

takayama@koto.kpu-m.ac.jp+81-75-251-5513

Outcome results

None listed

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