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

Condition(s) studied

Investigational drug(s) / intervention(s)

Pembrolizumab (neoadjuvant): Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

Cisplatin: Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Gemcitabine: 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: In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Sacituzumab tirumotecan: Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles

H1 receptor antagonist: Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

H2 receptor antagonist: Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Acetaminophen (or equivalent): Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Dexamethasone (or equivalent): Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label

Carboplatin: 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): After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles

Paclitaxel: 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): Administered orally as rescue medication 2-5 mL 4 times daily

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pathological Complete Response (pCR) — Up to approximately 20 weeks
  pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.
• Percent Residual Viable Tumor (%RVT) — Up to approximately 20 weeks
  %RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)

Trial sites (39)

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