A Study to Assess the effect of IMN 1207 vs Casein on survival, weight loss and quality of life in non-small cell lung cancer patients during or following chemotherapy, RT or surgery

Official Title

EFFECT OF IMN1207 VERSUS CASEIN ON SURVIVAL, WEIGHT LOSS AND QUALITY OF LIFE IN NON-SMALL CELL LUNG CANCER PATIENTS DURING OR FOLLOWING CHEMOTHERAPY, RADIATION OR SURGERY: A MULTI-CENTER RANDOMIZED, DOUBLE-BLIND STUDY

Summary:

The purpose of this study is to confirm the effect of a cysteine-rich non-heated whey protein formulation
IMN1207 on the reversal of weight loss (cancer-related wasting) and to test the hypothesis that IMN1207
administration (19.4 g protein daily) versus casein (19.4g protein daily) over a period of 40 weeks increases
the survival of non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy
or radiation. In addition, this study is prospectively designed to determine the effect of IMN1207 on the
quality of life in a defined subgroup of patients.

Trial Description

This trial is a multi-center, randomized double-blind study involving subjects with stage III or stage IV
non-small cell lung cancer. Fifty percent of subjects will receive the investigational study product IMN
1207 and the remaining subjects will receive a placebo in the form of casein. Neither the subject nor the
investigator will know into which group the subject has been placed. Subjects will be separately
randomized into two strata by an independent biostatistician based on their C-Reactive Protein (CRP)
levels and white blood cell (WBC) counts:
Stratum A: CRP <40 mg/L and WBC < 11x109/L (i.e. subjects with relatively low levels of
inflammation);
Stratum B: CRP ³ 40 mg/L and/or WBC ³ 11x109/L (i.e. subjects with relatively high levels of
inflammation.
Each stratum will be separately randomized into the two treatment arms. Note: At the end of the study the
two strata will be analyzed separately as well as collectively.