Ifinatamab Deruxtecan for Small Cell Lung Cancer
(IDeate-Lung02 Trial)
Recruiting in Palo Alto (17 mi)
+263 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Daiichi Sankyo
Must not be taking: B7-H3 agents, Topoisomerase inhibitors
Disqualifiers: Cardiovascular disease, Corneal disease, ILD, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
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.
What data supports the effectiveness of the drug Ifinatamab Deruxtecan (DS-7300, I-DXd) for treating small cell lung cancer?
Trastuzumab deruxtecan, a similar drug, has shown effectiveness in treating various cancers, including breast, gastric, and non-small cell lung cancer, by significantly extending survival and showing high response rates. This suggests that Ifinatamab Deruxtecan, which may have similar properties, could potentially be effective for small cell lung cancer.
12345What makes the drug Ifinatamab Deruxtecan unique for treating small cell lung cancer?
Ifinatamab Deruxtecan is unique because it is an antibody-drug conjugate, which means it combines an antibody (a protein that targets cancer cells) with a chemotherapy drug, allowing for targeted delivery to cancer cells, potentially reducing side effects compared to traditional chemotherapy.
678910Eligibility Criteria
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
+6 more
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
+6 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Ifinatamab deruxtecan (I-DXd)Experimental Treatment1 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 Control3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Health SystemDurham, NC
Mercy Medical CenterCanton, OH
Queen Elizabeth Ii Health Sciences CentreHalifax, Canada
Ucsf Mount Zion Medical CtrSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Daiichi SankyoLead Sponsor
Daiichi Sankyo, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. [2023]Label="PURPOSE">Trastuzumab deruxtecan (T-DXd) 5.4 and 6.4 mg/kg showed robust antitumor activity in multiple cancer indications; however, T-DXd 5.4 mg/kg has not been evaluated in patients with previously treated human epidermal growth factor receptor 2-mutant (HER2m; defined as single-nucleotide variants and exon 20 insertions) metastatic non-small-cell lung cancer (mNSCLC).
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. [2020]Trastuzumab deruxtecan (DS-8201a) is a novel HER2-targeted antibody-drug conjugate with a humanised anti-HER2 antibody, cleavable peptide-based linker, and potent topoisomerase I inhibitor payload. A phase 1, non-randomised, open-label, multiple-dose study was done to assess the safety, tolerability, and activity of trastuzumab deruxtecan in HER2-expressing, advanced solid tumours. The dose escalation (part 1) has previously been reported and the recommended doses for expansion of 5·4 mg/kg or 6·4 mg/kg were established. In this Article, we report the safety and preliminary activity results from this phase 1 trial in all patients with HER2-positive advanced-stage breast cancer with previous trastuzumab emtansine treatment who received trastuzumab deruxtecan at the recommended doses for expansion.
Trastuzumab deruxtecan in HER2-positive metastatic breast cancer and beyond. [2022]Despite the substantial improvements made in human epidermal growth factor receptor 2 (HER2)-targeted therapies since the approval of trastuzumab more than 20 years ago, there is still considerable unmet need in patients with HER2-expressing breast cancer (BC) and other solid tumors. Trastuzumab deruxtecan (T-DXd) is a newer antibody-drug conjugate approved for the treatment of metastatic breast cancer (BC) and gastric cancer (GC) and is under active investigation in other solid tumors, including non-small cell lung cancer, colorectal cancer, and HER2-low tumors.
Trastuzumab Deruxtecan DESTINY for Some Cancers. [2021]Trastuzumab deruxtecan may be effective in solid cancers in addition to breast cancer. In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy. It also elicited high response rates in phase II trials of HER2-mutant non-small cell lung cancer and HER2-positive colorectal cancer.
Trastuzumab Deruxtecan: First Approval. [2020]Trastuzumab deruxtecan (ENHERTU®), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate, is being developed for the treatment of HER2-expressing solid tumours, including breast cancer, gastric cancer, colorectal cancer and non-small cell lung cancer by Daiichi Sankyo Company Ltd in collaboration with AstraZeneca. Based primarily on the results of the phase 2 DESTINY-Breast01 trial, trastuzumab deruxtecan was recently approved in the USA under accelerated approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This article summarizes the milestones in the development of trastuzumab deruxtecan leading to this first approval.
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. [2022]Topotecan is approved as second-line treatment for small cell lung cancer (SCLC). Irinotecan is also frequently used given its more convenient schedule and superior tolerability. Preclinical studies support disialoganglioside (GD2) as an SCLC target and the combination of dinutuximab, an anti-GD2 antibody, plus irinotecan in this setting. We tested dinutuximab/irinotecan versus irinotecan or topotecan as second-line therapy in relapsed/refractory (RR) SCLC.
Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer. [2018]The irinotecan-cisplatin combination has emerged as a new standard for the treatment of advanced-stage small-cell lung cancer (AS-SCLC). To move forward we developed a 3-day regimen of cisplatin, etoposide and irinotecan.
Phase II study of a 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive-stage small-cell lung cancer. [2018]Irinotecan has been introduced to improve the treatment of small-cell lung cancer (SCLC). We conducted a trial involving a 3-week schedule of irinotecan combined with cisplatin (IP) to validate the efficacy and toxicity of this regimen in patients with previously untreated extensive-stage SCLC (ES-SCLC).
[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]. [2021]At present no standard second-line combination has been established for recurrent small cell lung cancer (SCLC). Therefore we evaluate the efficacy and safety of irinotecan in combination with nedaplatin/cisplatin against refractory or relapsed small cell lung cancer.
Chemotherapy for brain metastases in small-cell lung cancer. [2018]Brain metastasis occurs commonly in patients with small-cell lung cancer (SCLC). Herein, we report the efficacy of irinotecan and carboplatin in the treatment of brain metastases from SCLC. In addition, we review the existing data on chemotherapy for brain metastases in SCLC.