Non-small Cell Lung CancerPhase 1TroFuse-008NCT06049212
Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)
A Phase 1 study testing Sacituzumab tirumotecan, Pembrolizumab and Supportive care measures in people with Non-small Cell Lung Cancer and Solid Tumors, run by Merck Sharp & Dohme LLC at 7 sites in Japan.
Trial summary
This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Solid Tumors, Programmed Cell Death-1 (PD1, PD-1)
- What is being tested?
- Sacituzumab tirumotecan, Pembrolizumab and Supportive care measures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesJapan
- Study dates
- 26 Oct 2023to 29 Jan 2028
- Phase
- Phase 1
- 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
- Arm 1: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit.
- Arm 2: Have a histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC (Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC, AJCC Staging Manual, version 8).
- Arm 2: Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
- Arm 2: Has tumor tissue that demonstrates PD-L1 TPS ≥ 50% as determined by PD-L1 IHC 22C3 pharmDx assay by local laboratory
- If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (100 days for sacituzumab tirumotecan and 90 days for carboplatin [no restriction for pembrolizumab]) AND agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
- For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception
Show all 11Show fewer
- Arm 1: Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology
- Archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated has been provided
- Have a life expectancy of at least 3 months
- Have an ECOG performance status of 0 or 1 within 3 days before the start of study intervention
Who cannot join
- Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
- Received prior treatment with a TROP2-targeted ADC
Show all 27Show fewer
- Received prior treatment with a topoisomerase I-containing ADC
- Arm 1: Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Arm 2: Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- Arm 2: Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their advanced or metastatic NSCLC
- Arm 2: Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days before the first dose of study intervention and throughout the study
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Arm 2: Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Arm 2: Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Known active CNS metastases and/or carcinomatous meningitis
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- History of HIV infection
- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Known psychiatric or substance abuse disorder
- A severe hypersensitivity reaction to treatment a monoclonal antibody/component of the study intervention
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
National Cancer Center Hospital ( Site 0001)
Chuo-ku, Tokyo, 104-0045
Kansai Medical University Hospital ( Site 0007)
Hirakata, Osaka, 573-1191
National Cancer Center Hospital East ( Site 0002)
Kashiwa, Chiba, 277-8577
National Hospital Organization Shikoku Cancer Center ( Site 0008)
Matsuyama, Ehime, 791-0280
Shizuoka Cancer Center ( Site 0005)
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Aichi Cancer Center ( Site 0006)
Nagoya, Aichi-ken, 464-8681
Kanagawa Cancer Center ( Site 0004)
Yokohama, Kanagawa, 241-8515
About this study
Official title: Phase 1 Trial of MK-2870 as Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Subjects With Advanced Solid Tumors
This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC).
Per protocol amendment 04, Arm 3: Pembrolizumab/Carboplatin + sacituzumab tirumotecan Combination Therapy was discontinued, and subsequently all Arm 3 procedures, recruitment, and descriptions were removed.
- Conditions
- Non-small Cell Lung Cancer, Solid Tumors, Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
- Being tested
- Sacituzumab tirumotecan, Pembrolizumab, Supportive care measures
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanBiological
Also called SKB264, MK-2870
Sacituzumab tirumotecan injection powder for intravenous (IV) infusion.
PembrolizumabBiological
Also called MK-3475
Pembrolizumab solution for IV infusion.
Supportive care measuresDrug
Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sacituzumab tirumotecan Monotherapy | Experimental | Participants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W). Receives: Biological: Sacituzumab tirumotecan; Drug: Supportive care measures |
| Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy | Experimental | Participants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W). Receives: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Supportive care measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
A DLT is defined as any of the following: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or lymphopenia; any nonhematologic AE ≥Grade 3 in severity (with some exceptions); any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; a prolonged delay (>2 weeks) in initiating sacituzumab tirumotecan second dose due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during DLT evaluation period; or any Grade 5 toxicity. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Measured: Up to 21 days after each dose
Number of Participants Experiencing ≥1 Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to ~32 months
Number of Participants Discontinuing from Study Therapy due to AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to ~32 months
Secondary outcomes (28)
Area Under the Plasma Concentration-Time Curve (AUC) of sacituzumab tirumotecan -Antibody-Drug Conjugate (sacituzumab tirumotecan ADC)
The AUC of sacituzumab tirumotecan -ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Maximum Plasma Concentration (Cmax) of sacituzumab tirumotecan-ADC
The Cmax of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Minimum Plasma Concentration (Cmin) of sacituzumab tirumotecan-ADC
The Cmin of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Apparent terminal half-life (t½) of sacituzumab tirumotecan-ADC
The t½ of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Time to Maximum Plasma Concentration (Tmax) of sacituzumab tirumotecan-ADC
The Tmax of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Clearance (CL) of sacituzumab tirumotecan-ADC
The CL of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Volume of Distribution (Vz) of sacituzumab tirumotecan-ADC
The Vz of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Accumulation Ratio (Rac) of sacituzumab tirumotecan-ADC
The Rac of sacituzumab tirumotecan-ADC will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Area Under the Plasma AUC of sacituzumab tirumotecan-Total Antibody (sacituzumab tirumotecan-TAB)
The AUC of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmax of sacituzumab tirumotecan-TAB
The Cmax of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmin of sacituzumab tirumotecan-TAB
The Cmin of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
t½ of sacituzumab tirumotecan-TAB
The t½ of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Tmax of sacituzumab tirumotecan-TAB
The Tmax of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
CL of sacituzumab tirumotecan-TAB
The CL of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Vz of sacituzumab tirumotecan-TAB
The Vz of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Rac of sacituzumab tirumotecan-TAB
The Rac of sacituzumab tirumotecan-TAB will be determined in participants from Arm 1.
Measured: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmax of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
The Cmax of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmin of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
The Cmin of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
The Rac of sacituzumab tirumotecan-ADC when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmax of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
The Cmax of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmin of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
The Cmin of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
The Rac of sacituzumab tirumotecan-TAB when coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmax of KL610023 Coadministered with Pembrolizumab
The Cmax of KL610023 (free payload) when sacituzumab tirumotecan is coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of KL610023 Coadministered with Pembrolizumab
The Rac of KL610023 (free payload) when sacituzumab tirumotecan is coadministered with pembrolizumab will be determined in participants from Arm 2.
Measured: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to ~39 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause.
Measured: Up to ~39 months
Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan
The incidence of ADA will be determined in participants from Arm 1 and Arm 2.
Measured: Up to ~32 months
Incidence of Antidrug Antibodies (ADA) to pembrolizumab
The incidence of ADA will be determined in participants from Arm 2.
Measured: Up to ~32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start26 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049212
- Sponsor's protocol ID
- 2870-008
- Other IDs
- jRCT2031230356
- Acronym
- TroFuse-008
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of MK-2870 as Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06049212
- Acronym / sponsor ID
- TroFuse-008 / 2870-008
- Conditions
- Non-small Cell Lung Cancer, Solid Tumors, Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 22 Sep 2023 (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.
This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC).
Per protocol amendment 04, Arm 3: Pembrolizumab/Carboplatin + sacituzumab tirumotecan Combination Therapy was discontinued, and subsequently all Arm 3 procedures, recruitment, and descriptions were removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sacituzumab tirumotecan Monotherapy | Experimental | Biological: Sacituzumab tirumotecan, Drug: Supportive care measuresParticipants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W). |
| Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy | Experimental | Biological: Sacituzumab tirumotecan, Biological: Pembrolizumab, Drug: Supportive care measuresParticipants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Arm 1: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit.
- Arm 2: Have a histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC (Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC, AJCC Staging Manual, version 8).
- Arm 2: Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
- Arm 2: Has tumor tissue that demonstrates PD-L1 TPS ≥ 50% as determined by PD-L1 IHC 22C3 pharmDx assay by local laboratory
- If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (100 days for sacituzumab tirumotecan and 90 days for carboplatin [no restriction for pembrolizumab]) AND agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
Key exclusion criteria (27 listed)
- Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible
- Has Grade ≥2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
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 |
|---|---|---|
| Sacituzumab tirumotecanAlso: SKB264, MK-2870Sacituzumab tirumotecan injection powder for intravenous (IV) infusion. | Biological | Arm 1: Sacituzumab tirumotecan Monotherapy, Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy |
| PembrolizumabAlso: MK-3475Pembrolizumab solution for IV infusion. | Biological | Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy |
| Supportive care measuresParticipants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions | Drug | Arm 1: Sacituzumab tirumotecan Monotherapy, Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Time frame: Up to 21 days after each dose
A DLT is defined as any of the following: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia or lymphopenia; any nonhematologic AE ≥Grade 3 in severity (with some exceptions); any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); febrile neutropenia Grade 3 or Grade 4; a prolonged delay (>2 weeks) in initiating sacituzumab tirumotecan second dose due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during DLT evaluation period; or any Grade 5 toxicity. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Number of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to ~32 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Discontinuing from Study Therapy due to AE
Time frame: Up to ~32 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
28 secondary outcomes
Area Under the Plasma Concentration-Time Curve (AUC) of sacituzumab tirumotecan -Antibody-Drug Conjugate (sacituzumab tirumotecan ADC)
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Maximum Plasma Concentration (Cmax) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Minimum Plasma Concentration (Cmin) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Apparent terminal half-life (t½) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Time to Maximum Plasma Concentration (Tmax) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Clearance (CL) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Volume of Distribution (Vz) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Accumulation Ratio (Rac) of sacituzumab tirumotecan-ADC
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Area Under the Plasma AUC of sacituzumab tirumotecan-Total Antibody (sacituzumab tirumotecan-TAB)
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmax of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmin of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
t½ of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Tmax of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
CL of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Vz of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Rac of sacituzumab tirumotecan-TAB
Time frame: Day 1: Preinfusion and 0.5, 2, 4, 8, 24, 48, and 72 hours postinfusion
Cmax of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmin of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of sacituzumab tirumotecan-ADC Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmax of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmin of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of sacituzumab tirumotecan-TAB Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Cmax of KL610023 Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Rac of KL610023 Coadministered with Pembrolizumab
Time frame: Cycle 1 and 2: Days 1 and 29 preinfusion and 0.5 hours postinfusion (each cycle is 29 days)
Objective Response Rate (ORR)
Time frame: Up to ~39 months
Duration of Response (DOR)
Time frame: Up to ~39 months
Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan
Time frame: Up to ~32 months
Incidence of Antidrug Antibodies (ADA) to pembrolizumab
Time frame: Up to ~32 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 2 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sacituzumab tirumotecan, Pembrolizumab and Supportive care measures in people with Non-small Cell Lung Cancer and Solid Tumors, run by Merck Sharp & Dohme LLC at 7 sites in Japan.
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 11 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (time frame: Up to 21 days after each dose). The study lists 3 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 2 Sep 2026.