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Study of Sigvotatug Vedotin Plus Pembrolizumab for NSCLC

This study is investigating a combination treatment for non-small cell lung cancer (NSCLC) in people with high levels of PD-L1. You may be eligible if you have Stage IIIB, IIIC, or IV NSCLC and your cancer cells show high levels of PD-L1 (a protein that can stop the immune system from attacking cancer). The study compares Sigvotatug Vedotin plus Pembrolizumab to Pembrolizumab alone. All participants will receive Pembrolizumab every 6 weeks by IV. Half will also receive Sigvotatug Vedotin every 2 weeks by IV. Researchers will measure how long participants live and how long they live without their cancer growing or spreading.

Study design
This interventional study plans to enroll 714 participants. It compares a combination treatment to a single treatment.
What's involved
All participants will receive Pembrolizumab intravenously every 6 weeks. Half of the participants will also receive Sigvotatug Vedotin intravenously every 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for approximately 2 years to track overall survival and progression-free survival.

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NCT06758401

This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~714 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Sigvotatug VedotinPembrolizumab

At a glance

Recruiting sites
326 of 372 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival
Measured over Baseline to date of death from any cause (Approximately 2 years)
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung (NSCLC)

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Where it's being run

372 sites across 177 states
Minnesota13
Texas13
Turkey (Türkiye)10
Spain9
Santiago Metropolitan8
Germany8
Nebraska7
Argentina7

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

(Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.
Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose. 3. Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received. 4. Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy. 5. Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor 16. History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV. 17. Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months

What this trial measures

  • Overall SurvivalBaseline to date of death from any cause (Approximately 2 years)

    Overall survival defined as the duration from enrollment to death.

  • Progression Free Survival (PFS) assessed by blinded independent central review (BICR)From Baseline to to date of first documentation of progression OR death (Approximately 2 year)

    Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.