Ifinatamab Deruxtecan for Small Cell Lung Cancer

(IDeate-Lung02 Trial)

Not currently recruiting at 366 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Daiichi Sankyo

Must not be taking: B7-H3 agents, Topoisomerase inhibitors

Disqualifiers: Cardiovascular disease, Corneal disease, ILD, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: 21-day cycles, up to 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Ifinatamab Deruxtecan for people with small cell lung cancer (SCLC) that has returned after initial treatment. The study aims to determine if this drug is more effective and safer than other treatments chosen by doctors. Participants will receive either the new drug or a standard option, such as topotecan or lurbinectedin. It suits individuals previously treated with a platinum-based therapy for SCLC who are now experiencing disease progression. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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, which suggests that some medications might need to be paused before starting the trial. It's best to discuss your current medications with the trial team.

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

Research has shown that Ifinatamab Deruxtecan is generally tolerable for people with small cell lung cancer, with manageable side effects. One study found that about 12.4% of patients developed interstitial lung disease due to the treatment, with some cases being serious. However, the treatment's overall safety aligns with expectations for this type of cancer therapy. While there are some risks, most patients can handle the treatment well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

Unlike the standard treatments for small cell lung cancer, which typically involve chemotherapy drugs like topotecan or lurbinectedin, Ifinatamab Deruxtecan (I-DXd) offers a novel approach. I-DXd is an antibody-drug conjugate, which means it combines a targeted antibody with a potent anti-cancer drug. This allows it to precisely deliver the drug to cancer cells, potentially reducing side effects and enhancing effectiveness. Researchers are excited about I-DXd because its targeted mechanism could improve outcomes for patients by directly attacking cancer cells while sparing healthy ones.

What evidence suggests that Ifinatamab Deruxtecan might be an effective treatment for small cell lung cancer?

Research has shown that Ifinatamab Deruxtecan, which participants in this trial may receive, holds promise for treating small cell lung cancer. In earlier studies, about 48.2% of patients responded well, with nearly half experiencing a noticeable reduction in tumor size. The treatment has a high success rate, and its side effects can be managed. The U.S. FDA has recognized its potential by granting it a Breakthrough Therapy Designation. These findings suggest it could be a strong option for those whose small cell lung cancer has returned. Participants in another arm of this trial will receive a treatment of the physician's choice, which may include topotecan, lurbinectedin, or amrubicin. ^{1 2 5 6 7}

Who Is on the Research Team?

Global Clinical Director

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed Small Cell Lung Cancer who've had at least one platinum-based treatment. They must have a good performance status, measurable cancer growth after recent therapy, and can have treated brain metastases if they're symptom-free.

Inclusion Criteria

I can provide a sample of my tumor that is large and high-quality enough for testing.

Participants must have at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator

Participants must sign and date the informed consent form prior to the start of any study-specific qualification procedures

Exclusion Criteria

I have a serious eye condition affecting my cornea.

I have not been treated with orlotamab, enoblituzumab, or similar drugs targeting B7-H3.

Participants who have inadequate washout period before randomization as specified in the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Ifinatamab Deruxtecan (I-DXd) or Treatment of Physician's Choice (TPC) until a treatment discontinuation criterion is met

21-day cycles, up to 5 years

Day 1 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Ifinatamab Deruxtecan

Trial Overview The study compares Ifinatamab Deruxtecan (I-DXd), a new drug, against the physician's choice of Topotecan, Lurbinectedin or Amrubicin in patients with relapsed SCLC to see which is more effective and safer.

How Is the Trial Designed?

Group I: Ifinatamab deruxtecan (I-DXd) Experimental Treatment 1 Intervention

Participants randomized to receive 12 mg/kg I-DXd monotherapy on Day 1 of each 21-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.

Group II: Treatment of Physician's Choice (TPC) Active Control 3 Interventions

Participants randomized to receive topotecan, lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead 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

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Merck Sharp & Dohme LLC

Industry 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

Published Research Related to This Trial

The combination of irinotecan and cisplatin in a 3-week schedule for treating extensive-stage small-cell lung cancer (ES-SCLC) resulted in a high objective response rate of 89.3% among 28 previously untreated patients, indicating strong efficacy.

The treatment was associated with manageable toxicity, with significant grade 3/4 hematological toxicity (neutropenia) occurring in 26.9% of cycles, while non-hematological toxicities were rare, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of a 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive-stage small-cell lung cancer. Lee, JE., Park, HS., Jung, SS., et al.[2018]

In a study of 54 patients with recurrent small cell lung cancer, both irinotecan combined with nedaplatin and irinotecan combined with cisplatin showed similar efficacy, with median progression-free survival of 5.4 months and 4.9 months, respectively.

The treatment regimens were found to be effective and tolerable, with mild toxicities; however, the irinotecan and nedaplatin combination had higher hematologic toxicity, while the irinotecan and cisplatin combination resulted in more diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A retrospective study of the efficacy and toxicity of irinotecan in combination with nedaplatin versus irinotecan in combination with cisplatin as salvage treatment in refractory or relapsed small cell lung cancer]. Yu, S., Wang, Y., Hu, X., et al.[2021]

In a study involving 471 patients with relapsed/refractory small cell lung cancer, the combination of dinutuximab and irinotecan did not improve overall survival compared to irinotecan or topotecan alone, with median survival times of 6.9, 7.0, and 7.4 months respectively.

The safety profile showed that dinutuximab/irinotecan was associated with significant adverse events like neutropenia and anemia, but overall, irinotecan alone was found to be comparably effective to topotecan, suggesting that the combination therapy may not offer additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer. Edelman, MJ., Dvorkin, M., Laktionov, K., et al.[2022]

In a phase II trial involving 80 patients with small-cell lung cancer (SCLC), the combination of irinotecan and carboplatin showed a 65% response rate in patients with brain metastases after just 2 cycles of treatment, indicating its efficacy.

The median survival for patients with brain metastases treated with this chemotherapy regimen was 6 months, which is comparable to existing literature showing response rates and survival ranging from 22% to 85% and 3 to 9 months, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy for brain metastases in small-cell lung cancer. Chen, G., Huynh, M., Chen, A., et al.[2018]

Trastuzumab deruxtecan has shown significant effectiveness in treating HER2-positive gastric and gastroesophageal junction cancers, extending overall survival and progression-free survival compared to standard chemotherapy in a randomized phase II trial.

The drug also demonstrated high response rates in phase II trials for HER2-mutant non-small cell lung cancer and HER2-positive colorectal cancer, suggesting its potential efficacy across various solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Deruxtecan DESTINY for Some Cancers. [2021]

Trastuzumab deruxtecan (ENHERTU®) is an innovative treatment that combines an antibody targeting HER2 with a DNA topoisomerase I inhibitor, specifically designed for HER2-expressing solid tumors, including various types of cancer.

It received accelerated approval in the USA based on the promising results from the phase 2 DESTINY-Breast01 trial, which focused on patients with advanced HER2-positive breast cancer who had already undergone multiple treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Deruxtecan: First Approval. Keam, SJ.[2020]

In a phase 1 trial involving 115 patients with HER2-positive breast cancer previously treated with trastuzumab emtansine, trastuzumab deruxtecan demonstrated a manageable safety profile, with 59.5% of patients achieving a confirmed objective response.

Despite some serious treatment-emergent adverse events, including cases of interstitial lung disease and pneumonitis, the preliminary efficacy results suggest that trastuzumab deruxtecan is a promising treatment option, warranting further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Tamura, K., Tsurutani, J., Takahashi, S., et al.[2020]

Trastuzumab deruxtecan (T-DXd) is a promising new antibody-drug conjugate that has been approved for treating HER2-positive metastatic breast cancer and gastric cancer, showing potential for use in other solid tumors as well.

T-DXd is expected to become the standard second-line treatment for HER2-positive metastatic breast cancer and may also benefit patients with hormone receptor-positive and triple-negative breast cancer that express low levels of HER2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab deruxtecan in HER2-positive metastatic breast cancer and beyond. Perez, J., Garrigós, L., Gion, M., et al.[2022]

In a phase II study involving 152 patients with HER2-mutant metastatic non-small-cell lung cancer, trastuzumab deruxtecan (T-DXd) showed a confirmed objective response rate of 49% at 5.4 mg/kg and 56% at 6.4 mg/kg, indicating robust antitumor activity.

The safety profile of T-DXd was generally manageable, with fewer severe adverse events reported in the 5.4 mg/kg group compared to the 6.4 mg/kg group, suggesting that the lower dose may be preferable for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. Goto, K., Goto, Y., Kubo, T., et al.[2023]

The ECI regimen, which combines irinotecan, cisplatin, and etoposide over three days, demonstrated a high response rate of 77% in advanced-stage small-cell lung cancer patients, indicating its efficacy as a treatment option.

The maximum tolerated dose of irinotecan was established at 140 mg/m², with manageable side effects including febrile neutropenia and grade 3 diarrhea, suggesting that the regimen is well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer. Briasoulis, E., Samantas, E., Kalofonos, H., et al.[2018]

Citations

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

Ifinatamab Deruxtecan in Patients With Extensive-Stage ... I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. ... small cell lung cancer (NSCLC): Interim results of ...

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 ... Ifinatamab Deruxtecan Demonstrates High Response Rate in Previously Treated Extensive-Stage Small Cell Lung Cancer: Phase 2 IDeate-Lung01 Trial.

4. 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. Download the PDF version of Article. August 18, 2025. Data ... outcomes of those facing this aggressive disease.

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 was efficacious and had a manageable safety profile in patients with previously treated extensive-stage small cell lung ...

6. jto.org jto.org/article/S1556-0864(23)00844-4/fulltext

OA05.05 Ifinatamab Deruxtecan (I-DXd; DS-7300) in ... I-DXd demonstrated robust and durable efficacy in this subset of patients with heavily pretreated SCLC. Likewise, it was tolerable with manageable toxicity.

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

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