Anamorelin Hydrochloride for Non-Small Cell Lung Cancer

Overseen By Sriram Yennu

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP 3A4 inhibitors, Antiarrhythmics

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug Anamorelin Hydrochloride different from other drugs for non-small cell lung cancer?

Anamorelin Hydrochloride is unique because it is designed to address cancer-related cachexia (weight loss and muscle wasting) in non-small cell lung cancer patients, which is not the primary focus of standard chemotherapy drugs like cisplatin or pemetrexed. This makes it a novel option for improving quality of life by targeting symptoms that are not directly addressed by traditional cancer treatments. ^{1 2 3 4 5}

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Pemetrexed and gemcitabine versus carboplatin and gemcitabine in non-small cell lung cancer: a randomized noninferiority phase II study in one center. [2022]

3. Greece 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A randomized, multicenter phase II study comparing efficacy, safety and tolerability of two dosing regimens of cisplatin and pemetrexed in patients with advanced or metastatic non-small-cell lung cancer. [2022]