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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
05/03/2019
Funder:
MRC
Sponsor:
UCL
Chief Investigator:
Professor Sam Janes
Recruitment target:
Phase I: 6 -12; Phase II: 46
EudraCT number:
2015-005526-18
Contact details:
ctc.tactical@ucl.ac.uk
Lay summary:
TACTICAL
Targeted stromal cells expressing TRAIL as a therapy for lung cancer
Description
Design:
Phase I:
Single site dose de-escalation design with a modified Bayesian continual reassessment method (mCRM) to estimate the recommended Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin and/or pembrolizumab therapy.
Phase II:
Multicentre, randomised double blinded placebo controlled trial comparing MSCTRAIL at the RP2D and standard of care therapy versus standard of care therapy alone.

Treatment:
Phase I:
Pemetrexed 500mg/m2, day 1
Cisplatin 75mg/m2, day 1
MSCTRAIL cells day 2
MSCTRAIL is to be administered on day 2 of cycles 1-3 at the dose specified by the Cancer Trials Centre (CTC) at the time of registration. There will be up to three cohorts: Dose Level 1: 4x10^8 cells (per cycle); Dose Level 2: 2x10^8 cells (per cycle); Dose Level 3: 8x10^7 cells (per cycle).
Each patient will receive 3 cycles of MSCTRAIL with pemetrexed/cisplatin followed by a 4th cycle of pemetrexed/cisplatin only (without MSCTRAIL). Each cycle is 21 days in duration. After completion of the four cycles of trial treatment, the patients will revert to local standard of care therapy as decided by their treating clinician.
Phase II:
Control arm:
Pemetrexed 500mg/m2, day 1
Cisplatin 75mg/m2, day 1
Placebo, day 2
Patients will receive 3 cycles of placebo with pemetrexed/cisplatin followed by a 4th cycle of pemetrexed/cisplatin only (without placebo). Each cycle is 21 days in duration.
Investigational arm:
Pemetrexed 500mg/m2, day 1
Cisplatin 75mg/m2, day 1
MSCTRAIL cells day 2 (at dose established in Phase I)
Patients will receive 3 cycles of MSCTRAIL with pemetrexed/cisplatin followed by a 4th cycle of pemetrexed/cisplatin only (without MSCTRAIL). Each cycle is 21 days in duration.
After completion of the four cycles of trial treatment, the patients will revert to local standard of care therapy as decided by their treating clinician.
Key inclusion/exclusion criteria:
Inclusion criteria:
1. Inoperable stage IIIb/IV histologically /cytologically confirmed lung adenocarcinoma
2. PD-L1 expression ALK mutation negative
3. Patients with unmeasurable but evaluable disease can be included in the phase I study, but disease must be measurable to be included in the phase II study.
4. ECOG performance status of 0 or 1
5. Age at least 18 years
6. Adequate haematological status: Haemoglobin 100g/L or greater; Neutrophil count ≥1.5 x 10^9/L, Platelets ≥100 x 10^9 /L
7. Adequate organ function: Bilirubin ≤1.5 x ULN; ALT or AST ≤3 x ULN; Creatinine clearance ≥ 60 ml/min 
Exclusion criteria
1. Prior chemotherapy, hormonal therapy, radiotherapy (including palliative radiotherapy), immunotherapy or treatment with
investigational drugs for advanced NSCLC; prior treatment with any cellular therapy; any surgical procedure in the previous 6 weeks
2. Known respiratory failure with baseline resting SpO2
3. Known WHO Class III or IV pulmonary hypertension
4. Severe intercurrent infection; active or infected wounds
5. Vaccination with any live attenuated vaccine within 30 days prior to trial registration/randomisation
6. 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
7. Evidence of symptomatic brain metastases requiring treatment
8. 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
9. Venous thromboembolism within the last 6 months
Duration of recruitment:
Phase I: 12 months
Phase II: 24 months

Aim
To evaluate the safety and anti-tumour activity of MSCTRAIL in addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC)

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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