A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab tirumotecan — BIOLOGICAL
  Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
• Pembrolizumab — BIOLOGICAL
  Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
• Cisplatin — DRUG
  Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
• Pemetrexed — DRUG
  Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
• Gemcitabine — DRUG
  Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
• Carboplatin — DRUG
  Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
• Paclitaxel — DRUG
  Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
• Rescue medication — DRUG
  Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Study Details

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Key Dates

Start date

Apr 3, 2024

Status verified

May 2026

Primary completion

Feb 21, 2034

Completion

Oct 23, 2034

Study Design

Enrollment

780 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Sacituzumab tirumotecan
  Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).
• Active Comparator: Pembrolizumab
  Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).

Primary Outcome Measure

Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to ~ 93 months ]

Central Contacts

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

Locations (49)

Find similar trials in Little Rock, AR

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