Selecting cancer patients for treatment using Tumor Organoids, the SENSOR study

Completed

• Conditions: colon cancer; Colorectal cancer; lung cancer; non-small cell lung cancer; 10017991

• Registration Number: NL-OMON46891
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-04-16
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

1. Patients with locally advanced (incurable) or metastatic colorectal cancer or NSCLC that have only one line standard of care treatment left, or will start with a study treatment. Patients should have received a first line standard of care treatment.
2. No treatment options with curative intent
3. RECIST 1.1 measurable/evaluable disease
4. Safe biopsy of a metastatic lesion possible
5. Adequate organ function
6. WHO performance status 0-1
7. Age > 18 years and written informed consent;In- and exclusion criteria for each drug are further determined by individual drug characteristics that are provided by pharmaceutical partners.

Exclusion Criteria

1. Pregnant or lactating (nursing) women
2. Prior malignancy within 5 years.
3. Known infection with human immunodeficiency virus (HIV)
4. Leptomeningeal carcinomatosis
5. Symptomatic brain metastasis.
6. Other psychiatric or medical conditions that would make the patient unfit for participation.
7. Life expectancy of less than 3 months from tumor progression under standard of care. ;In- and exclusion criteria for each drug are further determined by individual drug characteristics that are provided by pharmaceutical partners.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall clinical response rate (ORR) according to RECIST 1.1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Progression free survival (PFS) per RECIST 1.1.<br /><br>* Progression free survival per RECIST 1.1 per compound or combination of<br /><br>compounds.<br /><br>* Overall response rate (ORR) per RECIST 1.1 per compound or combination of<br /><br>compounds.<br /><br>* Incidence and severity of adverse events per compound or combination of<br /><br>compounds.</p><br>