Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer

Launched by UNIVERSITY COLLEGE, LONDON · Sep 29, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for lung cancer, specifically a type called adenocarcinoma. The treatment involves using special stem cells that have been modified to help fight the cancer. The goal is to see how safe this new treatment is when given alongside standard chemotherapy drugs, cisplatin and pemetrexed. During the trial, patients will receive chemotherapy on the first day, and then the stem cells on the second day, repeated over three cycles spaced out every three weeks.

To participate in this study, patients must be adults aged 18 and older with advanced lung cancer that cannot be surgically removed. They should also meet certain health criteria, like having a good overall health status and not having prior treatments for their lung cancer. The trial involves random assignment, meaning some patients will receive the new stem cell treatment while others will receive a placebo, which looks the same but has no active ingredients. Throughout the trial, both patients and healthcare providers will not know who is receiving the actual treatment or the placebo to ensure fairness in the results. This trial is currently recruiting participants, and it aims to provide valuable information on the safety and effectiveness of this new approach to lung cancer treatment.

Gender

ALL

Eligibility criteria

• • 1. Inoperable stage IIIb/IV histologically/cytologically confirmed lung adenocarcinoma
• • 2. EGFR mutation and EML4-ALK translocation negative
• • 3. Patients with evaluable but unmeasurable disease can be included in the phase I study, but disease must be measurable (CT scan must be within 28 days of randomisation) to be included in the phase II study
• • 4. ECOG performance status of 0 or 1
• • 5. Life expectancy of at least 12 weeks
• • 6. Age at least 18 years
• 7. Adequate haematological status:
• • 1. Haemoglobin ≥100g/L
• • 2. Neutrophil count ≥1.5 x 109/L
• • 3. Platelets ≥100 x 109 /L
• 8. Adequate organ function:
• • 1. Bilirubin ≤1.5 x ULN
• • 2. ALT or AST ≤3 x ULN (≤5 x ULN is acceptable with liver metastases)
• • 3. Creatinine clearance ≥ 60 ml/min (C\&G or EDTA)
• • 9. Negative pregnancy test for female patients of child bearing potential.
• • 10. Male subjects and women of child bearing potential must agree to use an acceptable method of birth control for the duration of the trial and for 12 months after the last trial treatment administration.
• • 11. Ability to understand and provide written informed consent
• • 12. Ability to comply with the requirements of the protocol
• Exclusion Criteria:
• • 1. Prior chemotherapy, hormonal therapy, radiotherapy (including palliative radiotherapy), immunotherapy or treatment with an investigational drug for advanced NSCLC.
• • 2. Any surgical procedure in the previous 6 weeks prior to registration/ randomisation
• • 3. Known respiratory failure with baseline resting SpO2 \<88%
• • 4. Long term oxygen therapy
• • 5. Severe intercurrent infection
• • 6. Active or infected wounds
• • 7. Yellow fever vaccination within 30 days prior to trial registration/randomisation
• • 8. Subject has known sensitivity to any of the trial drugs to be administered during the trial.
• • 9. Any contraindication to the administration and use of cisplatin, pemetrexed, vitamin B12 or folic acid
• • 10. Prior malignancy other than NSCLC (except if the tumour was a non-melanoma skin tumour that has been completely excised or in situ cervix carcinoma), unless have been treated with curative intent with no evidence of disease for \> 3 years
• • 11. Evidence of symptomatic brain metastases requiring treatment
• • 12. Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[New York Heart Association \> class II\]) within 1 year of enrolment
• • 13. Known inflammatory bowel disease
• • 14. Known hepatitis B or C infection, human immunodeficiency virus (HIV)-positive patients
• • 15. Pregnant women or those who are breast feeding
• • 16. Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, or may interfere with the interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial