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New treatment option for Lung Neoplasm
Official title 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)
ClinicalTrials.gov ID: NCT06780098
What this study is testing
What is R-DXD?
R-DXD is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung neoplasm.
Also referred to as Raludotatug deruxtecan, MK-5909.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an...
- 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...
You likely can't join if
- 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...
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has clinically significant corneal disease
See the full eligibility criteria
- The main include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death...
- 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
- 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...
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has clinically significant corneal disease
- Has previously received docetaxel as monotherapy or in combination with other therapies
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Evidence of any leptomeningeal disease
- Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require...
- 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
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Dallas, Texas, United States
- Santiago, Region M. de Santiago, Chile
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Tübingen, Baden-Wurttemberg, Germany
- Berlin, Germany
- Athens, Attica, Greece
- Thessaloniki, Greece
- Kecskemét, Bács-Kiskun county, Hungary
- Győr, Győr-Moson-Sopron, Hungary
- Szolnok, Jász-Nagykun-Szolnok, Hungary
- Haifa, Israel
- Jerusalem, Israel
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Baltimore, Maryland, United States; Dallas, Texas, United States; Santiago, Region M. de Santiago, Chile; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.