2023-509234-19-00RecruitingPhase 2
KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
Merck Sharp & Dohme LLC15 sites in 5 countries47 target enrollmentStarted: September 16, 2024Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 47
- Locations
- 15
- Primary Endpoint
- Pathological Complete Response (pCR)
Study Overview
Brief Summary
- To estimate the incidence of pCR in the resected primary tumor and lymph nodes assessed by BIPR following administration of investigational agents with various combinations of chemotherapy and pembrolizumab.
- To estimate the extent of residual viable tumor in the resected lung tumor/lymph node sections in relation to the total carcinoma area assessed by BIPR.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has previously untreated resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC), confirmed by pathology or imaging
- •Able to undergo protocol therapy, including necessary surgery
- •Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
- •Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
Exclusion Criteria
- •Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
- •Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- •Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Active infection requiring systemic therapy.
- •Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.
- •Known history of human immunodeficiency virus (HIV) infection
- •History of allogeneic tissue/solid organ transplant
- •Has Grade ≥2 peripheral neuropathy
- •Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- •Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- •Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Arms & Interventions
-
Auxiliary
Participants receiving -
Intervention: - (Drug)
Outcomes
Primary Outcomes
Pathological Complete Response (pCR)
Pathological Complete Response (pCR)
Percent Residual Viable Tumor (%RVT)
Percent Residual Viable Tumor (%RVT)
Secondary Outcomes
- Percentage of Participants Who Report at Least 1 Adverse Event (AE)
- Percentage of Participants Who Discontinue Study Treatment Due to an AE
- Event-free Survival (EFS)
- Overall Survival (OS)
- Distant Metastasis-Free Survival (DMFS)
- Objective Response Rate (ORR)
- Percentage of Participants Who Experience a Perioperative Complication
- Mean Length of Length of Hospital Stay
- Percentage of Participants Who Require Hospital Readmission after Discharge
- Mean Length of Surgery
- Percentage of Participants Who Require a Blood Transfusion
Investigators
Jeffrey Thompson
Scientific
Merck Sharp & Dohme LLC
Study Sites (15)
Loading locations...
Similar Trials
Recruiting
Phase 2
Clinical trial to compare efficacy and safety of standard chemotherapy versus letrozole plus abemaciclib, chosen randomly, as neoadjuvant therapy (deliver before breast cancer surgery), with positive Hormone Receptors (female hormones) and negative HER2 (protein involved in cell division that is located in the surface of many cells), intermediate/high risk breast cancer.2024-514395-40-00Fundacion Grupo Espanol De Investigacion En Cancer De Mama200
Active, not recruiting
Phase 1/2
SHR-9839 联合抗肿瘤治疗在实体瘤患者中的安全性、耐受性及有效性的 IB/II 期临床研究CTR2025431860
Recruiting
Phase 1
A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO- CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND BIOLOGICAL ACTIVITY OF TQS-168 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS2023-504746-54-00Tranquis Therapeutics Inc.16
Recruiting
Phase 2
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
Not yet recruiting
Phase 1
Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)Bladder CancerNCT07260162Institut Cancerologie de l'Ouest24