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RecruitingLast updated:15 August 2023

EVOKE 03: This study is comparing the effectiveness of immunotherapy plus targeted therapy, compared to immunotherapy alone, in people with metastatic non-small cell lung cancer with PD-L1 tumour proportion score (TPS) â‰¥50%An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)

Clinical summary Eligibilty Participating hospital Support

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two experimental arms. In Experimental Arm A, participants will receive immunotherapy (pembrolizumab) and targeted therapy (sacituzumab govitecan). They will receive sacituzumab govitecan (10mg/kg via intravenous [IV] infusion) once weekly on Day 1 and Day 8 of a continuous 21-day cycle, plus pembrolizumab (200mg via IV infusion) on Day 1 every 3 weeks. In Experimental Arm B, participants will receive immunotherapy (pembrolizumab) alone. Pembrolizumab (200mg via IV infusion) will be given on Day 1 every 3 weeks.

Treatment Type

Radiotherapy,Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People 18+

Phase

III

Trial Acronym

EVOKE 03

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

NCT05609968
3475-D46; MK-3475-D46; KEYNOTE D46

Commercial Sponsor

Merck Sharp & Dohme LLC

Scientific Title

An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater Than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)

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Eligibility

Inclusion

You have certain types of non-cancer medical conditions.
You have been diagnosed with a prior or secondary type of cancer.
You have had certain treatments, surgical procedures or drugs.
You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

Your cancer has spread to other parts of the body.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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