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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

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

Who can participate

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

Inclusion criteria

  • Liver metastatic 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 immune checkpoint inhibitor
  • Measurable disease
  • ECOG 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 metastasis more than 50%
  • Oxygen saturation less than 92% in room air
  • Prior autoimmune disorder
  • CNS metastasis
  • Major GI bleeding in the last 2 months
04

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

  • DrugRegorafenib Pill

    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

05

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

06

Study locations

3 of 3 sites recruiting
  • University of California, Irvine Medical Center
    Orange, California 92868, United States
    Recruiting
  • China Medical University Hsinchu Hospital
    Hsinchu, Taiwan
    Recruiting
  • Chung Shan Medical University Hospital
    Taichung, Taiwan
    Recruiting
07

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.

08

Registry details

Key details

Study ID
NCT04701476
Lead sponsor
Teclison Ltd.
Collaborators
Merck Sharp & Dohme LLC
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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