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Comparing Ifinatamab Deruxtecan to Physician's Choice for Relapsed Small Cell Lung Cancer

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

PHASE3 · Daiichi Sankyo · NCT06203210

This study is testing if a new drug called Ifinatamab deruxtecan can help people with relapsed small cell lung cancer more than the treatments their doctors usually choose.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo (industry)
Drugs / interventionsorlotamab, enoblituzumab, trastuzumab, chemotherapy, radiation
Locations230 sites (Springdale, Arkansas and 229 other locations)
Trial IDNCT06203210 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of Ifinatamab deruxtecan (I-DXd) compared to the treatment of physician's choice in patients with relapsed small cell lung cancer (SCLC). The primary goal is to determine if I-DXd can improve the objective response rate and overall survival compared to standard treatments. Additionally, the study will assess various secondary outcomes, including health economics, patient-reported outcomes, and the pharmacokinetics of I-DXd. Participants will be randomized to receive either I-DXd or one of the physician's chosen therapies.

Who should consider this trial

Good fit: Ideal candidates include adults with extensive-stage small cell lung cancer who have received one prior platinum-based therapy and have measurable disease progression.

Not a fit: Patients who have not received prior systemic therapy or those with limited-stage small cell lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with relapsed small cell lung cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar targeted therapies in small cell lung cancer, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

Participants must meet all the following criteria to be eligible for randomization into the study:

1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval of ≥30 days.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
8. Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system \[CNS\] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.

Exclusion Criteria

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.
4. Has inadequate washout period before randomization as specified in the protocol.
5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
6. Has uncontrolled or significant cardiovascular disease.
7. Has clinically significant corneal disease.
8. Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.

   Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Where this trial is running

Springdale, Arkansas and 229 other locations

+180 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Small Cell Lung Cancer, Small cell lung cancer, Ifinatamab deruxtecan, I-DXd

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.