Investigational Agents for Lung Cancer

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Antiretrovirals, HBV antivirals

Disqualifiers: Cardiovascular disorder, Pulmonary illness, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 60 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. Metastatic means the cancer has spread to other parts of the body. Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC. Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goals of this study are to learn about: * The cancer response to the study treatments compared to chemotherapy * The safety of the study treatments and if people tolerate them This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV squamous NSCLC who've had disease progression after one prior IO therapy, possibly with chemo. Participants can have well-controlled HIV on ART, or a history of Hepatitis B/C if they meet certain treatment criteria.

Inclusion Criteria

I had Hepatitis C but my viral load is now undetectable.

My lung cancer is Stage IV and squamous type.

My cancer progressed after one immune therapy treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational agents or Docetaxel every 3 weeks until progressive disease or discontinuation

Up to approximately 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 84 months

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• I-DXD
• R-DXD

Trial Overview The study compares antibody drug conjugates (ADCs), which are designed to target and kill cancer cells, against standard chemotherapy. The goal is to see if ADCs are more effective or safer than the usual treatments for this advanced lung cancer.

How Is the Trial Designed?

Group I: Arm 3: I-DXD Low Dose Experimental Treatment 1 Intervention

Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until progressive disease or discontinuation.

Group II: Arm 2: Infinatamab deruxtecan (I-DXD) High Dose Experimental Treatment 1 Intervention

Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until progressive disease or discontinuation.

Group III: Arm 1: Raludotatug deruxtecan (R-DXD) Experimental Treatment 1 Intervention

Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease or discontinuation.

Group IV: Arm 4: Docetaxel Active Control 1 Intervention

Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until progressive disease or discontinuation.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD