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RecruitingNCT04701476Updated Apr 16, 2026

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

A Phase 2 interventional study of TATE and pembrolizumab and TAS-102 pill in Colorectal Cancer; Lung Cancer, sponsored by Teclison Ltd.. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Teclison Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2021; still recruiting 5 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Read the detailed description

This study is an open-label study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.

02

Conditions studied

  • Colorectal Cancer; Lung Cancer

Keywords

  • colorectal cancer
  • NSCLC
  • pembrolizumab
  • tirapazamine
  • Liver metastasis
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 110 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Teclison Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Liver MSS-mCRC or NSCLC without EGFR or AKT mutations
  • mCRC progressed on at least two lines of standard chemotherapy; or
  • NSCLC progressed on chemotherapy and an
  • 0-1
  • At least 4 weeks from prior chemotherapy and free from chemo-related toxicity
  • Adequate organ function

Exclusion criteria

Exclusion Criteria:

  • Prior organ transplantation
  • Liver more than 50%
  • Oxygen saturation less than 92% in room air
  • Prior disorder
  • Major GI bleeding in the last 2 months
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    colorectal cancer

    metastatic colorectal cancer progressed on at least two lines of chemotherapy

    Drug: TATE and pembrolizumab · Drug: TAS-102 pill · Drug: Regorafenib Pill

  • Experimental
    NSCLC

    Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

    Drug: TATE and pembrolizumab

Interventions

  • DrugTATE and pembrolizumab

    All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.

    Also known as: TATE: Trans-arterial Tirapazamine Embolization;

  • DrugTAS-102 pill

    The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.

    Also known as: LONSURF

  • As an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.

    Also known as: STIVARGA

This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Overall Survival for the mCRC cohort

    From the first day of treatment to death

    Time frame: 24 months

  2. Overall Response Rate (ORR) for the NSCLC cohort

    Per RECIST 1.1 criteria

    Time frame: within 24 months

Secondary outcomes

  1. Duration of Response

    per RECIST 1.1

    Time frame: 24 months

  2. Response rate

    in TATE treated or TATE-untreated lesions by RECIST and mRECIST

    Time frame: 24 months

  3. PFS

    Progression Free Survival

    Time frame: 24 months

  4. TTP

    Time to Progression

    Time frame: 24 months

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — International meeting report or medical Journal publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04701476
Lead sponsor
Teclison Ltd.
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
May 20, 2021
Primary completion
Mar 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Ray Lee, MD. PhD.
Contact
ray.lee01@teclison.com
8043341076
Chiwei Lu
Contact
chiwei.lu4@teclison.com
Ray Lee
study director · Teclison Limited

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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