Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Launched by MERCK SHARP & DOHME LLC · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for patients with metastatic squamous non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread beyond the lungs. The standard treatments usually involve immunotherapy, which helps the body’s immune system fight cancer, and chemotherapy, which kills cancer cells. However, these treatments may not work for everyone, so researchers are looking at new drugs known as antibody drug conjugates (ADCs). These ADCs target cancer cells directly, aiming to shrink or eliminate the tumors that didn't respond to standard treatments.

To participate in this trial, potential candidates must have been diagnosed with stage IV squamous NSCLC and have shown that their cancer has progressed after receiving both immunotherapy and chemotherapy. Eligible participants include those who are between 65 and 74 years old and who meet specific health criteria, such as having well-managed HIV or certain hepatitis infections. Participants will receive the study treatments and doctors will monitor how well the cancer responds, as well as how safe and tolerable the treatments are. This study is still in the planning stages and has not yet started recruiting participants, so there may be more information available as it gets underway.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
• • Documented disease progression as assessed by investigator using RECIST 1.1 after receiving both anti-programmed cell death ligand 1 (anti-PD-\[L\]1) treatment and platinum-based chemotherapy per local standard of care
• • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
• • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• • Has uncontrolled or significant cardiovascular disorder
• • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
• • Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
• • Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including Human immunodeficiency virus (HIV) infection)
• • Has clinically significant corneal disease
• • Known additional malignancy that is progressing or has required active treatment within the past 3 years
• • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• • Evidence of any leptomeningeal disease
• • History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
• • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
• • Active infection requiring systemic therapy
• • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• • Concurrent active Hepatitis B (defined as Hepatitis B surface antigen (HBsAg) positive and/or detectable Hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
• • Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
• • Known history of, or active, neurologic paraneoplastic syndrome
• • History of allogeneic tissue/solid organ transplant
• • Has not adequately recovered from major surgery or have ongoing surgical complications