Study on Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan for Metastatic Squamous Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06422143

Provider View

This clinical trial is testing whether adding a drug called sacituzumab tirumotecan to pembrolizumab can improve survival in patients with metastatic squamous non-small cell lung cancer. The study involves initial treatment with pembrolizumab and chemotherapy, followed by maintenance therapy with pembrolizumab alone or with sacituzumab tirumotecan.

Patient Parameters

Program Overview

This study is exploring a treatment for metastatic squamous non-small cell lung cancer (NSCLC) using pembrolizumab combined with chemotherapy drugs carboplatin and paclitaxel (or nab-paclitaxel). After the initial treatment phase, participants will continue with pembrolizumab alone or with an additional drug, sacituzumab tirumotecan, to see if this combination improves overall survival.

Description

Participants in this study will first receive four cycles of treatment, each lasting three weeks. This initial phase includes pembrolizumab, carboplatin, and either paclitaxel or nab-paclitaxel. After this, participants will be randomly assigned to continue with pembrolizumab alone or with the addition of sacituzumab tirumotecan for maintenance therapy. The study aims to determine if the combination of pembrolizumab and sacituzumab tirumotecan is more effective than pembrolizumab alone in extending the lives of patients with metastatic squamous NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic squamous non-small cell lung cancer (NSCLC).
  • Have measurable disease based on specific medical criteria.
  • Expected to live at least 3 more months.
  • In good general health with a performance status score of 0 or 1.
  • Able to provide a tumor sample for analysis.
  • If HIV-positive, must have well-controlled HIV on treatment.
  • If hepatitis B positive, must have undetectable viral load after treatment.
  • If previously infected with hepatitis C, must have undetectable viral load.
  • Any side effects from past cancer treatments must be mild or resolved.
  • Have adequate organ function.
  • For maintenance phase: no disease progression after initial treatment, good health status, and recovery from any side effects.

Exclusion Criteria

  • Have small cell lung cancer or mixed tumors with small cell elements.
  • Have severe nerve damage (Grade 2 or higher).
  • Have severe eye conditions that affect healing.
  • Have active inflammatory bowel disease needing treatment.
  • Have uncontrolled heart or blood vessel disease.
  • Have certain HIV-related conditions.
  • Have received prior treatment for metastatic NSCLC.
  • Have received certain immune therapies or investigational drugs recently.
  • Have had recent radiation therapy to the lung or other areas.
  • Have received a live vaccine recently.
  • Have not recovered from major surgery.
  • Have another progressing cancer needing treatment.
  • Have untreated or unstable brain metastases.
  • Have severe allergies to study drugs.
  • Have active autoimmune disease needing treatment.
  • Have lung disease needing steroids.
  • Have active infection needing treatment.
  • Have had a tissue or organ transplant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.