Investigational Agents for Non-Small Cell Lung Cancer

Recruiting at 7 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Small cell lung cancer, Cardiovascular disorder, Pulmonary compromise, Active infection, 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 24 months

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments

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 nonsquamous NSCLC who've had the cancer grow after one prior immune therapy, possibly with chemo. They should have a life expectancy of at least 3 months, be relatively active (ECOG status 0-1), and have organs working well. Participants must not be pregnant or breastfeeding and must use effective contraception.

Inclusion Criteria

My cancer does not require treatments targeting EGFR, ALK, or ROS1 genes.

I am fully active or restricted in physically strenuous activity but can do light work.

I have provided a sample of my tumor that has not been treated with radiation.

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have an immunodeficiency or am on long-term steroids.

I have another cancer that has gotten worse or needed treatment in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either raludotatug deruxtecan, ifinatamab deruxtecan, or docetaxel via IV infusion every 3 weeks until disease progression or discontinuation criterion is met

Up to approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 60 months

Long-term follow-up

Participants are monitored for overall survival

Up to approximately 84 months

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Ifinatamab Deruxtecan
• Raludotatug Deruxtecan

Trial Overview The study tests two antibody drug conjugates (ADCs) - Ifinatamab Deruxtecan and Raludotatug Deruxtecan - against standard chemotherapy to see if they're safe, tolerated, and effective in treating metastatic nonsquamous NSCLC that didn't respond to previous treatments.

How Is the Trial Designed?

Group I: Raludotatug Deruxtecan Experimental Treatment 1 Intervention

Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met.

Group II: Ifinatamab Deruxtecan Experimental Treatment 1 Intervention

Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met.

Group III: Docetetaxel Active Control 1 Intervention

Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met.

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