A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06731907
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab 200mg IV Infusion.
  • Carboplatin — DRUG
    Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m\^2 IV infusion.
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel 100mg/m\^2 IV infusion.
  • Pemetrexed — DRUG
    Pemetrexed 500mg/m\^2 IV infusion.
  • HER3-DXd — BIOLOGICAL
    HER3-Dxd 5.6mg/kg IV infusion.

Study Details

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

Key Dates

Start date
Mar 30, 2025
Status verified
May 2026
Primary completion
Mar 12, 2032
Completion
Mar 12, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pembrolizumab and Chemotherapy
    Pembrolizumab will be administered as a 200mg IV infusion on Day 1 of every three weeks (Q3W) for up to 35 cycles (\~ 2 years). The doublet platinum-based chemotherapy treatments used in this substudy are standard-of care regimens for squamous (paclitaxel/Nab-paclitaxel and carboplatin) and nonsquamous (pemetrexed and carboplatin) NSCLC. Pemetrexed is administered as a 500mg/m\^2 IV infusion Q3W until discontinuation criterion is met. Nab-paclitaxel will be administered as a 100mg/m\^2 IV infusion on Days 1, 8, and 15 Q3W for up to 4 cycles. Paclitaxel will be administered as a 200 mg/m\^2 IV infusion on Day 1 Q3W for up to 4 cycles. Carboplatin will be administered as an IV infusion area under the time x concentration curve (AUC) for 4 cycles as per local practice and labels. The dose will be AUC5 or 6 mg/mL•min Q3W and will not exceed 900mg.
  • Experimental: Pembrolizumab and HER3-DXd
    Pembrolizumab will be administered as a 200mg IV infusion on Day 1 Q3W for up to 35 cycles (\~ 2 years). HER3-Dxd will be administered as 5.6mg/kg IV infusion on Day 1 Q3W until discontinuation criteria is met.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to ~ 5 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Kentucky ( Site 0019)LexingtonKentucky40536
Study Coordinator
859-218-0131
MedStar Franklin Square Medical Center ( Site 0033)BaltimoreMaryland21237
Study Coordinator
443-777-7147
Sanford Fargo Medical Center ( Site 0039)FargoNorth Dakota58102
Study Coordinator
701-234-2000
Abramson Cancer Center ( Site 0010)PhiladelphiaPennsylvania19104
Study Coordinator
215-220-9703
Sanford Cancer Center ( Site 0038)Sioux FallsSouth Dakota57104
Study Coordinator
605-838-8631

Find similar trials in Lexington, KY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Kentucky· Lexington, KYMedStar Franklin Square Medical Center· Baltimore, MDSanford Fargo Medical Center· Fargo, NDAbramson Cancer Center· Philadelphia, PASanford Cancer Center· Sioux Falls, SD

Related Studies