Targeted stem cell therapy for lung cancer

Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer

This study is testing a new stem cell therapy combined with chemotherapy to see if it can help people with advanced lung cancer feel better and fight their disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University College, London (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (London)
• Trial ID: NCT03298763 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and anti-tumor activity of MSCTRAIL, a targeted stem cell therapy, in combination with chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC). In the Phase I portion, patients will receive a combination of cisplatin and pemetrexed followed by MSCTRAIL cells to determine the recommended dose for Phase II. The Phase II portion will randomize patients to receive either the MSCTRAIL therapy or a placebo alongside standard chemotherapy. The study aims to assess the efficacy of this novel treatment approach compared to conventional methods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with inoperable stage IIIb/IV lung adenocarcinoma who are negative for EGFR mutations and EML4-ALK translocations.

Not a fit: Patients with operable lung cancer or those with specific genetic mutations like EGFR or EML4-ALK may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option that enhances the effectiveness of chemotherapy for lung cancer patients.

How similar studies have performed: While this approach is innovative, similar studies using targeted therapies in lung cancer have shown promise, indicating potential for success.

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

Where this trial is running

London

• University College London Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Sam Janes — Ucl
• Study coordinator: TACTICAL Trial Coordinator

Conditions Adenocarcinoma of Lung