Investigational Agents for Non-Small Cell Lung Cancer

Recruiting at 16 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?

This trial tests two new treatments for non-small cell lung cancer that has spread and hasn't responded to standard treatments. The focus is on two experimental drugs called antibody drug conjugates (ADCs), designed to target and destroy cancer cells. These include Ifinatamab Deruxtecan and Raludotatug Deruxtecan. Researchers will compare these new treatments to traditional chemotherapy to determine which is more effective and safer. Suitable participants have lung cancer that didn't shrink after standard treatments like immunotherapy or chemotherapy. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

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, there is a mention of an 'inadequate washout period' as an exclusion criterion, which suggests that some medications might need to be stopped before starting the trial. It's best to discuss your specific medications with the trial team.

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

Earlier studies found ifinatamab deruxtecan to be generally safe, with no new safety issues. This indicates that individuals previously treated for advanced lung cancer tolerated the treatment well.

Similarly, raludotatug deruxtecan showed promising results in animal studies, with researchers noting its safety for those tests.

Both treatments are now undergoing phase 2 trials in humans. This phase helps researchers learn more about the safety and potential effectiveness of these treatments in people. While animal studies and earlier human studies offer some safety insights, the current trial will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Ifinatamab Deruxtecan and Raludotatug Deruxtecan because they offer a novel approach to treating non-small cell lung cancer. Most treatments for this condition, like chemotherapy and targeted therapies, work by attacking cancer cells directly or interfering with specific growth pathways. In contrast, these investigational drugs are antibody-drug conjugates, which means they combine an antibody that specifically targets cancer cells with a potent chemotherapy agent. This targeted approach aims to deliver the chemotherapy directly to cancer cells, potentially increasing effectiveness while reducing harm to healthy cells. This innovative mechanism of action is what sets these treatments apart from traditional options.

What evidence suggests that this trial's treatments could be effective for metastatic nonsquamous non-small cell lung cancer?

Research has shown that ifinatamab deruxtecan, an investigational agent in this trial, achieved a promising response rate of 48.2% in patients with previously treated lung cancer. Nearly half of these patients saw their cancer respond to the treatment. Additionally, 87.6% of patients experienced disease control, meaning their cancer either stopped growing or started shrinking. While raludotatug deruxtecan, another investigational agent in this trial, lacks direct data, similar treatments have significantly improved survival times for patients with advanced non-small cell lung cancer. This suggests that these treatments could offer new hope for patients whose cancer hasn't responded to standard therapies. ^{2 5 6 7 8}

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

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 Results: Overall, 183 patients received I-DXd: 88 in part 1 (8 mg/kg, n=46; 12 mg/kg, n=42) and 95 in part 2. The median number of prior lines ...

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 ...

6. daiichisankyo.us daiichisankyo.us/press-releases/-/article/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer

Ifinatamab Deruxtecan Granted Breakthrough Therapy ... Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05280470

NCT05280470 | Ifinatamab Deruxtecan (I-DXd) in Subjects ... This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12536792/

IDeate-Lung02: a Phase 3 study of second-line ifinatamab ... [Google Scholar]; •• Clinical data showing antitumour activity of I-DXd in patients with advanced solid tumours, including small cell lung cancer. 30. Johnson M ...