Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer

NCT03637816 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2017-1059NCI-2018-01593
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II/III trial studies how well anamorelin hydrochloride works in reducing anorexia in patients with non-small cell lung cancer that has spread to other places in the body. Anamorelin hydrochloride may help to improve patients' appetite in order to stop weight loss.

Conditions

Anorexia; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• To reach thematic saturation by qualitatively examining experiences related to anorexia at the baseline in advanced lung cancer patients with anorexia/cachexia receiving either oral Anamorelin 100 mg or placebo.

  A 60-90 minute interview will be conducted to identify and explore a range of issues, including: impact on daily psycho-social function (relationships, work, mood, initiative, pleasurable activities); food intake; independence; physiological changes in appetite/eating; visuality of cachexia; weight loss interpreted as a "bad sign"; response from health care professionals; conflict over food; coping responses; and the patient's report of meaningful change in symptoms due to the intervention (and if so, why).

  Baseline up to day 64

Secondary Outcomes (9)

• Explore changes in anorexia/cachexia in patients with advanced non-small cell cancer after oral anamorelin 100 mg/placebo treatment

  Baseline up to day 64

• Explore changes in anorexia after 9 weeks of oral Anamorelin 100 mg or placebo treatment

  Baseline up to day 64

• Explore associations between changes in anorexia and body composition assessed with body weight in kilograms and (lean body mass in kilograms).

  Baseline up to day 64

• Explore associations between changes in anorexia with nutrition assessed by serum pre-albumin, Insulin Growth Factor-1 (IGF-1), and IGF binding protein-3 (IGFBP-3).

  Baseline up to day 64

• Explore associations between changes in anorexia with inflammation assessed by C-Reactive Protein (CRP), monocyte IL-6&R, TNF-α&R, IL-10,IL-8,IL-1&RA) inflammatory biomarkers.

  Baseline up to day 64

Study Arms (2)

Arm I (anamorelin hydrochloride)

EXPERIMENTAL

Patients receive anamorelin hydrochloride PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

Drug: Anamorelin Hydrochloride; Other: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

Other: Placebo; Other: Questionnaire Administration

Interventions

Anamorelin Hydrochloride DRUG

Given PO

Also known as: RC-1291 HCl

Arm I (anamorelin hydrochloride)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (anamorelin hydrochloride); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of advanced non-small cell lung cancer
• Presence of anorexia, defined as =\< 37 points on FAACT A/CS domain (on a 0 to 48-point scale in which 0 = worst possible anorexia/cachexia)
• Patients with a history of either: \>= 5% of weight loss for body mass index (BMI) \>= 20 kg/m\^2 or \>= 2% of weight loss for BMI \< 20 kg/m\^2, over a period of 1 year
• Patients must be willing to keep a daily medication diary and engage in telephone follow up with research staff
• Patients must have telephone access to allow contact by the research staff
• Adequate hepatic function, defined as aspartate transaminase (AST) and alanine transaminase (ALT) levels =\< 5 x upper limit of normal (ULN)
• Life expectancy of \>= 6 months

You may not qualify if:

• Major contraindication to anamorelin i.e. hypersensitivity
• BMI \>= 28 kg/m\^2
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
• Uncontrolled diabetes mellitus (fasting blood sugar \> 200 mg/dl) at screening
• Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
• Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
• Patients currently on investigational therapies will be evaluated by the principal investigator (PI) on a case by case basis and study participation approval will be obtained from the treating oncologist
• Patient currently taking androgenic compounds (including but not limited to testosterone, testosterone-like agents, oxandrolone, megestrol acetate, methylphenidate, corticosteroids \[note: topical, inhaled, or oral corticosteroids taken for a short duration (=\< 5 consecutive days) after chemotherapy are acceptable\]), dronabinol or medical marijuana (medical cannabis) or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss
• Any relevant condition that would interfere with ability to participate in one-on-one interviews either in person or via telephone

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yennurajalingam S, Mott F, Lu Z, Urbauer D, Stanton P, Torres H, Rantanen PA, Davis S, Dev R, Hui D, Bruera E. Perception of subjective lived experiences of individuals with anorexia-cachexia in patients with advanced lung cancer. Asia Pac J Oncol Nurs. 2023 Oct 10;10(Suppl 1):100314. doi: 10.1016/j.apjon.2023.100314. eCollection 2023 Nov.

  PMID: 38197040 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Anorexia; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

anamorelin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 20, 2018
• Study Start: November 27, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)