The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.

Inclusion Criteria:

• Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
• Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
• Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
• Age ≥ 18 years
• Written informed consent

Exclusion Criteria:

• Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
• Received radiotherapy within 2 months prior to the study
• Weight loss >10% in the last 6 months
• Body Mass Index < 20.0 kg/m2
• Life expectancy < 3 months
• Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
• Presence of ileostoma or ileal pouch
• Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
• Known pregnancy or lactation
• Current alcohol or drug abuse in the opinion of the investigator
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

randomised controlled, open label, parallel-group, multi-centre and multicountry study