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Checkpoint Inhibitor

Pembrolizumab + Sacituzumab Tirumotecan for Lung Cancer

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Histologically or cytologically confirmed diagnosis of squamous squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~79 months
Awards & highlights

Summary

"This trial is testing pembrolizumab with chemotherapy followed by pembrolizumab alone or with another drug for treating advanced lung cancer. The goal is to see if adding the second drug helps

Who is the study for?
This trial is for adults with a specific type of advanced lung cancer called metastatic squamous NSCLC. They must have good organ function, provide a tumor tissue sample, and have measurable disease. People with controlled hepatitis B or C can join; those with HIV must be stable on ART. It's not suitable for individuals who haven't recovered from previous cancer treatment side effects.
What is being tested?
The study tests pembrolizumab combined with chemotherapy (carboplatin/taxane), followed by either continued pembrolizumab alone or with an additional drug called sacituzumab tirumotecan (sac-TMT). The goal is to see if adding sac-TMT improves survival compared to just pembrolizumab after initial treatment.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions, fatigue, changes in blood counts which could increase infection risk, and potential liver issues. Side effects vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have provided a sample of my tumor that has not been treated with radiation.
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My lung cancer is confirmed as stage IV squamous NSCLC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~79 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~79 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Arm 1: Pembrolizumab + sac-TMTExperimental Treatment2 Interventions
During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) after receipt of an antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), and dexamethasone (or equivalent) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Group II: Maintenance Arm 2: Pembrolizumab MonotherapyActive Control1 Intervention
During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,132 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,929 Total Patients Enrolled
~567 spots leftby Jan 2029
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