The study is expected to include 460 individuals that will be randomly treated with 12mg of ifinatamab deruxtecan or chemotherapy chosen by the health care provider.
Merck has recently announced the initiation of their Ideate-Lung02 (NCT06203210) trial—a global, multicenter, randomized, open-label phase 3 study that assesses the efficacy and safety of ifinatamab deruxtecan (I-DXd; Daiichi Sankyo) to treat individuals with relapsed small cell lung cancer (SCLC).1,2
The study authors noted that I-DXd is a potential first-in-class B7-H3 directed DXd antibody-drug conjugate (ADC), a transmembrane protein that binds to programmed death-ligand 1. B7-H3 has displayed overexpression in various cancer types, including SCLC, which is associated with poor prognosis. As a humanized anti-B7-H3 IgG1 monoclonal antibody, I-DXd attaches to topoisomerase I inhibitor payloads, according to study authors.1
SCLC is a fast-growing cancer that occurs in the lung tissues, impacting 15% of all 2.48 million lung cancer cases globally. Individuals diagnosed with SCLC could experience chest comfort or pain, recurrent cough, trouble breathing, wheezing, loss of appetite, fatigue, and swelling in the face or/and veins in the neck, according to study authors.3 Since SCLC is aggressive, and it can progress to the metastatic stage quickly—which only has a 3% 5-year survival rate.1
“Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head of oncology clinical development at Daiichi Sankyo, in a news release.“The IDeate-Lung02 trial is an important next step as we look to better understand the role of ifinatamab deruxtecan as a potential new medicine for patients with certain types of small cell lung cancer.”1
The IDeate-Lung02 phase 3 study was based on results from the Ideate-PanTumor01 phase1/2 trial that assessed I-DXd among individuals with advanced solid malignant tumors.4 The current study evaluates the efficacy of I-DXd compared to amrubicin, lurbinectedin or topotecan chemotherapy among individuals with relapsed SCLC following disease progression with 1 prior line of platinum-based chemotherapy.1
Trial Name: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (IDeate-Lung02)
ClinicalTrials.gov ID: NCT06203210
Sponsor: Daiichi Sankyo
Completion Date (Estimated): February 2029
“The initiation of the IDeate-Lung02 trial for ifinatamab deruxtecan marks the second pivotal study since the start of our collaboration with Daiichi Sankyo and follows the recent initiation of the REJOICE-Ovarian01 Phase 2/3 study for raludotatug deruxtecan,” said Marjorie Green, MD, senior vice president and head of oncology for global clinical development at Merck Research Laboratories, in a news release.1
The study is expected to include 460 individuals that will be randomly assigned to receive 12mg of I-DXd or a chemotherapy chosen by the health care provider. The authors noted that the primary endpoint includes objective response rate and overall survival, assessed by blinded independent central review. Additionally, the secondary endpoint includes duration of response, disease control rate and time to response, also assessed by blinded independent central review.1,2
“This is a significant milestone as we work together to evaluate an innovative medicine that may have the potential to make a meaningful difference in the lives of people facing small cell lung cancer, a difficult-to-treat cancer,” said Green in the news release.1
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