UPCC 15518 / ANAM-17-21: A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

UPCC 15518 / ANAM-17-21: A Phase 3  Randomized  Double-Blind  Placebo-Controlled  Multicenter Study to Evaluate the Efficacy and Safety of anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Brief description of study

The main purpose of this study is to learn more about how well the experimental drug, anamorelin hydrochloride (HCl), works to prevent weight loss and anorexia in patients with advanced Non-Small Cell Lung Cancer.

Detailed description of study

The loss of enjoyment of food and weight loss has shown to decrease the quality of life for cancer patients. Additionally, poor eating and weight loss affects patients’ overall health, making them increasingly tired and more likely to experience side effects from their cancer treatments. Some patients have to take lower doses of cancer-fighting treatments or stop using them altogether.
Anamorelin HCl, works by mimicking a naturally occurring substance in the body that causes increased appetite and weight gain.

Additional Information
This study is a randomized, double-blind, placebo-controlled study. "Placebo-controlled" means that some patients will take tablets containing the study drug and some patients will take tablets that do not contain any medication (placebo). "Randomized" means that you will be assigned to a treatment randomly, like flipping a coin. You have an equal chance of being assigned to receive the study drug or the placebo.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    BMI
  • Age: Between 18 Years - 99 Years
  • Gender: All

  1. Female or male ≥18 years of age
  2. Documented diagnosis of  Stage III or IV Non-Small Cell Lung Cancer.
  3. Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months  prior to screening.

Updated on 24 Jul 2023. Study ID: 832183

Interested in the study

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