Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

Conditions

• Lung Neoplasm Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab (neoadjuvant) — BIOLOGICAL
  Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
• Cisplatin — DRUG
  Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
• Gemcitabine — DRUG
  In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.
• Pemetrexed — DRUG
  In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
• Sacituzumab tirumotecan — DRUG
  Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
• H1 receptor antagonist — DRUG
  Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
• H2 receptor antagonist — DRUG
  Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
• Acetaminophen (or equivalent) — DRUG
  Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
• Dexamethasone (or equivalent) — DRUG
  Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
• Carboplatin — DRUG
  AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles
• Pembrolizumab (adjuvant) — BIOLOGICAL
  After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
• Paclitaxel — DRUG
  Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.
• Steroid mouthwash (dexamethasone or equivalent) — DRUG
  Administered orally as rescue medication 2-5 mL 4 times daily

Study Details

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Key Dates

Start date

Mar 20, 2025

Status verified

May 2026

Primary completion

Feb 6, 2032

Completion

Feb 6, 2032

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pembrolizumab + Platinum
  Neoadjuvant: Prior to surgery pembrolizumab 200 mg every three weeks (Q3W) for 4 cycles (each cycle is 21 days); Cisplatin 75 mg/m\^2 Q3W with gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or paclitaxel 175 mg/m\^2 or 200 mg/m\^2 q3w (any histology) OR Carboplatin AUC 5 mg/mL• min or AUC 6 mg/mL• min with paclitaxel 175 mg/m\^2 or 200 mg/m\^2 Q3W (any histology), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors); followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days).
• Experimental: Pembrolizumab + Sacituzumab tirumotecan
  Neoadjuvant: Prior to surgery pembrolizumab 200 mg Q3W for 4 cycles (each cycle is 21 days); sacituzumab tirumotecan 4 mg/kg Q2W for 6 cycles (each cycle is 14 days), followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days). Optional adjuvant platinum-based doublet chemotherapy up to 4 cycles may be given at the investigator's discretion.

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: Up to approximately 20 weeks ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (8)

Find similar trials in Daphne, AL

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