Investigational Agents for Lung Cancer

Recruiting at 28 trial locations

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?

This trial tests new treatments for metastatic squamous non-small cell lung cancer (NSCLC), where the cancer has spread to other parts of the body. Researchers are examining whether two new antibody drug conjugates (ADCs), I-DXD and R-DXD, can effectively treat this cancer when standard treatments, such as immunotherapy and chemotherapy, have failed. Participants will receive either one of the experimental drugs or a standard chemotherapy drug for comparison to assess the cancer's response and the safety of the new treatments. This trial seeks individuals with stage IV squamous NSCLC that has worsened despite previous treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from cutting-edge therapies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiretroviral therapy for HIV or antiviral therapy for Hepatitis B, you should continue those treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown promising safety results for Raludotatug deruxtecan (R-DXD). Tested in patients with platinum-resistant ovarian cancer, it was found to be safe, allowing many patients to continue treatment without major issues. This suggests R-DXD might also be safe for other cancer types.

Research indicates that Infinatamab deruxtecan (I-DXD) is generally well-tolerated, though some patients experienced side effects. About 89.8% of patients had side effects, mostly mild. More serious side effects were less common, occurring in about 36.5% of patients, with only a few needing to stop treatment.

Both treatments are being explored in this trial due to their potential benefits and manageable safety profiles demonstrated in earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because R-DXD and I-DXD offer innovative approaches to treating lung cancer. Unlike traditional chemotherapy agents like Docetaxel, which target rapidly dividing cells, R-DXD and I-DXD are antibody-drug conjugates. This means they can deliver chemotherapy directly to cancer cells, minimizing damage to healthy cells. R-DXD is designed to target specific cancer cell markers with precision, while I-DXD offers a new mechanism of action by delivering a potent cytotoxic payload directly to the tumor. These features could potentially lead to more effective treatments with fewer side effects.

What evidence suggests that this trial's treatments could be effective for metastatic squamous NSCLC?

This trial will compare different investigational agents for lung cancer. Research has shown that raludotatug deruxtecan (R-DXD), which participants in this trial may receive, led to tumor shrinkage in 50% of patients in previous studies on other cancers, such as ovarian cancer. This suggests it might also be promising for lung cancer. Similarly, infinatumab deruxtecan (I-DXD), another treatment option in this trial, showed a 48.2% success rate in shrinking tumors in patients with other types of lung cancer. These treatments target cancer cells directly and deliver medicine to destroy them. Both R-DXD and I-DXD have demonstrated effectiveness in treating difficult cancers, offering hope for those with advanced squamous non-small cell lung cancer. ^{1 2 3 4 5}

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 PD 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 PD 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 (PD) 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 PD 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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-02142

Ifinatamab Deruxtecan in Patients With Extensive-Stage ... Conclusion. I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent ...

2. merck.com merck.com/news/ifinatamab-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-extensive-stage-small-cell-lung-cancer-in-ideate-lung01-phase-2-trial/

Ifinatamab Deruxtecan Demonstrated Clinically Meaningful ... September 7, 2025 10:45 am EDT. An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated ...

3. iaslc.org iaslc.org/iaslc-news/press-release/ifinatamab-deruxtecan-demonstrates-high-response-rate-previously-treated

Ifinatamab Deruxtecan Demonstrates High Response Rate ... At the March 3, 2025 data cutoff, 137 patients had received I-DXd after one (23.4%), two (54.7%), or three (21.9%) prior lines of systemic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41086386/

Primary Analysis of the Phase 2 IDeate-Lung01 Trial Conclusion: I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent ...

5. onclive.com onclive.com/view/ifinatamab-deruxtecan-elicits-responses-in-previously-treated-extensive-stage-small-cell-lung-cancer

Ifinatamab Deruxtecan Elicits Responses in Previously ... Ifinatamab deruxtecan showed a 48.2% ORR and 87.6% DCR in previously treated ES-SCLC patients, with rapid and durable responses. Median PFS was ...