Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas

Key Inclusion criteria:

   1. Patients must sign an informed consent before assessment

   2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV
   non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV
   adenocarcinoma of the pancreas.

   3. Patients with stage IV NSCLC will be receiving or completed or discontinued standard
   chemotherapy or be chemotherapy-naive by choice.

   4. Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard
   chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in
   chemotherapy is not expected.

   5. Greater than or equal to 5% unintentional weight loss over the previous 3-6 months,
   not explained by simple starvation. Simple starvation is considered to be excluded
   when weight loss is not ameliorated by standard nutritional counseling and oral
   supplementation over a 2 week period.

   6. Body mass index (BMI) ≤ 30 kg/m2.

   7. Life expectancy of at least 4 months.

   8. Able to communicate well and comply with the requirements of the study, including by
   phone and written logs.

Key Exclusion criteria:

   1. Patients who have received investigational anti-neoplastic therapy within 3 weeks of
   screening

   2. Evidence of inadequate organ or brain function, as defined by lab tests and imaging

   3. Patients with severe and/or uncontrolled medical conditions that could interfere with
   the study (e.g. heart conditions, high blood pressure, diabetes, infection)
   uncontrolled pain or any other non-stable illness

   4. Pregnant or lactating women.

   5. Women capable of becoming pregnant must use highly effective contraception during the
   study and for 8 weeks after stopping treatment. All female patients must have negative
   pregnancy test results throughout the study

   6. Patients unwilling or unable to follow instructions.

Other protocol-defined inclusion/exclusion criteria may apply.