Colorectal Cancer; Lung CancerPhase 2NCT04701476
TATE and Pembrolizumab (MK3475) in mCRC and NSCLC
A Phase 2 study testing TATE and pembrolizumab, TAS-102 pill and Regorafenib Pill in people with Colorectal Cancer; Lung Cancer, run by Teclison Ltd. at 3 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer; Lung Cancer
- What is being tested?
- TATE and pembrolizumab, TAS-102 pill and Regorafenib Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 20 May 2021to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Chiwei Lu contact
3 sites in 2 countries
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hsinchu Hospital
Hsinchu
sandy Lai, sandy6618@teclison.com
- Recruiting
Chung Shan Medical University Hospital
Taichung
Sandy Lai, sandy6618@teclison.com
United States1 site, 1 recruiting
- Recruiting
University of California, Irvine Medical Center
Orange, California, 92868
Miranda Duron, mnduron@hs.uci.edu
About this study
Official title: An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab
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.
- Conditions
- Colorectal Cancer; Lung Cancer
- Being tested
- TATE and pembrolizumab, TAS-102 pill, Regorafenib Pill
- Keywords
- colorectal cancer, NSCLC, pembrolizumab, tirapazamine, Liver metastasis
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TATE and pembrolizumabDrug
Also called TATE: Trans-arterial Tirapazamine Embolization;
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.
TAS-102 pillDrug
Also called LONSURF
The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.
Regorafenib PillDrug
Also called STIVARGA
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.
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer | Experimental | metastatic colorectal cancer progressed on at least two lines of chemotherapy Receives: Drug: TATE and pembrolizumab; Drug: TAS-102 pill; Drug: Regorafenib Pill |
| NSCLC | Experimental | Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy Receives: Drug: TATE and pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival for the mCRC cohort
From the first day of treatment to death
Measured: 24 months
Overall Response Rate (ORR) for the NSCLC cohort
Per RECIST 1.1 criteria
Measured: within 24 months
Secondary outcomes (4)
Duration of Response
per RECIST 1.1
Measured: 24 months
Response rate
in TATE treated or TATE-untreated lesions by RECIST and mRECIST
Measured: 24 months
PFS
Progression Free Survival
Measured: 24 months
TTP
Time to Progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start20 May 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer; Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teclison Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ray Lee, Study director, Teclison Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701476
- Sponsor's protocol ID
- LT-007
- Other IDs
- KEYNOTE-A91
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: International meeting report or medical Journal publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab
- ClinicalTrials.gov ID
- NCT04701476
- Acronym / sponsor ID
- LT-007
- Conditions
- Colorectal Cancer; Lung Cancer
- Keywords
- colorectal cancer, NSCLC, pembrolizumab, tirapazamine, Liver metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Teclison Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer | Experimental | Drug: TATE and pembrolizumab, Drug: TAS-102 pill, Drug: Regorafenib Pillmetastatic colorectal cancer progressed on at least two lines of chemotherapy |
| NSCLC | Experimental | Drug: TATE and pembrolizumabLiver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Prior organ transplantation
- Liver metastasis more than 50%
- Oxygen saturation less than 92% in room air
- Prior autoimmune disorder
- CNS metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TATE and pembrolizumabAlso: TATE: Trans-arterial Tirapazamine Embolization;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. | Drug | NSCLC, colorectal cancer |
| TAS-102 pillAlso: LONSURFThe comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off. | Drug | colorectal cancer |
| Regorafenib PillAlso: STIVARGAAs 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. | Drug | colorectal cancer |
Primary outcome
Overall Survival for the mCRC cohort
Time frame: 24 months
From the first day of treatment to death
Overall Response Rate (ORR) for the NSCLC cohort
Time frame: within 24 months
Per RECIST 1.1 criteria
4 secondary outcomes
Duration of Response
Time frame: 24 months
Response rate
Time frame: 24 months
PFS
Time frame: 24 months
TTP
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. International meeting report or medical Journal publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiwei Lu contact
Ray Lee study director
Teclison Limited
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TATE and pembrolizumab, TAS-102 pill and Regorafenib Pill in people with Colorectal Cancer; Lung Cancer, run by Teclison Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray Lee, MD. PhD. (8043341076, ray.lee01@teclison.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival for the mCRC cohort (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.