Anamorelin Hydrochloride for Non-Small Cell Lung Cancer

Overseen By Sriram Yennu

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP 3A4 inhibitors, Antiarrhythmics

Disqualifiers: Hypersensitivity, BMI >= 28, Pregnancy, Uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well anamorelin hydrochloride reduces anorexia (loss of appetite) in patients with advanced non-small cell lung cancer that has spread. The goal is to determine if this treatment can improve appetite and prevent weight loss. Participants will receive either the actual drug or a placebo (a substance with no active ingredient) daily for 9 weeks. The trial seeks participants diagnosed with advanced non-small cell lung cancer who are experiencing appetite loss and noticeable weight loss. As an Early Phase 1 trial, this study focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as strong CYP 3A4 inhibitors, drugs that may affect heart rhythms, androgenic compounds, and medications intended to increase appetite or treat weight loss. If you're on these, you may need to stop them before participating.

Is there any evidence suggesting that anamorelin hydrochloride is likely to be safe for humans?

Research has shown that anamorelin hydrochloride is generally safe for use. In one study, patients with advanced lung cancer who took anamorelin for 24 weeks found it both safe and effective. Another study on patients with non-small cell lung cancer found that anamorelin improved appetite and muscle mass without major safety issues. These studies suggest that anamorelin is safe, but further research is needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Anamorelin hydrochloride is unique because it targets the ghrelin receptor to stimulate appetite and increase lean body mass, which is particularly beneficial for patients with non-small cell lung cancer experiencing cancer cachexia, a condition characterized by severe weight loss and muscle wasting. Unlike traditional treatments that primarily focus on directly attacking cancer cells, such as chemotherapy drugs or targeted therapies, anamorelin addresses the critical issue of weight and muscle loss, potentially improving quality of life and treatment outcomes. Researchers are excited about this treatment because it offers a novel approach to managing cancer-related symptoms, which could complement existing therapies and provide a more holistic treatment strategy for patients.

What evidence suggests that anamorelin hydrochloride might be an effective treatment for anorexia in non-small cell lung cancer?

Research has shown that anamorelin hydrochloride, which participants in this trial may receive, can improve appetite and body composition in people with advanced non-small cell lung cancer. Studies have found that this treatment increases appetite and muscle mass, which is crucial for managing cancer-related weight loss. Anamorelin also enhances physical abilities and reduces symptoms, improving patients' quality of life. Other research suggests it works effectively without causing major side effects. Overall, promising evidence indicates that anamorelin can help manage anorexia and cachexia (muscle and weight loss) in lung cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-small cell lung cancer who are experiencing anorexia (loss of appetite) and weight loss. They must have a life expectancy of at least 6 months, be able to use the phone for follow-ups, and keep a medication diary. Pregnant women or those not using contraception are excluded, as well as patients on certain medications or with uncontrolled diabetes.

Inclusion Criteria

I have lost more than 5% of my weight in a year and my BMI is 20 or higher, or I have lost more than 2% of my weight in a year and my BMI is less than 20.

I am willing to keep a daily medication diary and talk on the phone with research staff.

I have a phone for research staff to contact me.

Exclusion Criteria

You have any condition that would make it hard for you to take part in one-on-one interviews in person or over the phone.

Your body mass index (BMI) is 28 or higher.

You have a major reason why you cannot take anamorelin, such as being very sensitive or allergic to it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral anamorelin hydrochloride or placebo daily for 9 weeks

9 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anamorelin Hydrochloride

Trial Overview The trial is testing Anamorelin Hydrochloride's effectiveness in improving appetite and preventing weight loss in patients with advanced non-small cell lung cancer. Participants will either receive this drug or a placebo while their condition is monitored through questionnaires.

How Is the Trial Designed?

Group I: Arm I (anamorelin hydrochloride) Experimental Treatment 2 Interventions

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

Group II: Arm II (placebo) Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cisplatin-based chemotherapy is preferred for treating advanced nonsmall cell lung cancer, with carboplatin as an alternative for patients with contraindications; nonplatinum regimens are also available for those who cannot tolerate platinum-based treatments.

There is no evidence that higher doses of cisplatin improve survival compared to standard doses, and a minimum of four to six cycles of chemotherapy is recommended for patients who respond well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. Sculier, JP., Moro-Sibilot, D.[2018]

Cisplatin alone was found to be the most effective treatment for A549 lung cancer cells, showing the highest cytotoxicity compared to both pemetrexed alone and the combination of cisplatin and pemetrexed.

The combination therapy of cisplatin and pemetrexed induced significant autophagy and reduced cellular senescence, but was less effective than cisplatin monotherapy in inhibiting KRAS-dependent pathways and promoting cell death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin and Pemetrexed Have Distinctive Growth-inhibitory Effects in Monotherapy and Combination Therapy on KRAS-dependent A549 Lung Cancer Cells. Mohiuddin, M., Kasahara, K.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5834076/

ROMANA 3: a phase 3 safety extension study of ... These results demonstrate that anamorelin is well tolerated in advanced NSCLC patients with cachexia over the 12–24w treatment period that constituted the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01387282

Safety and Efficacy of Anamorelin HCl in Patients With Non ... The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jcsm.13732

Anamorelin Efficacy in Non–Small‐Cell Lung Cancer ... Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic ...

4. nature.com nature.com/articles/s41598-023-42446-x

The efficacy and safety of anamorelin for patients ... Our results suggest that anamorelin improves TBW, LBM, and QOL without increasing systemic AEs from soon after the start to 12 weeks of ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04743-9/fulltext

451P The real-world efficacy and safety of anamorelin ... Anamorelin showed significant improvement of appetite in unresectable lung cancer patients with CACS. Earlier administration may bring out the favorable effects ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT147675

A safety extension study of anamorelin in advanced non- ... A safety extension study of anamorelin in advanced non-small cell lung cancer patients with cachexia: ROMANA 3. · Author Details · David Christopher Currow.