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A Phase 1b/2, Study of I-DXd in Combination with Atezolizumab with or without Carboplatin in First-line ES‑SCLC
EU CTIS ID: 2023-509629-36-00
What this study is testing
Part A and Part B: To assess the safety and tolerability of I-DXd in combination with atezolizumab with or without 4 cycles of carboplatin.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures.
- A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively. a. Avoid donating sperm. Note: Preservation of sperm should be considered prior to enrolment / randomization in this trial. b. Adhere to either of the following contraception methods: i. True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject, OR ii. Uses a penile/external condom when having penile-vaginal intercourse with a non-subject of childbearing potential PLUS partner use of an additional contraceptive method, as a condom may break or leak. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study drugs are more stringent than the requirements above, the local label requirements are to be followed. Note: If the subject is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the subject’s medical records, medical examination, or medical history interview), no contraception is required.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Has histologically or cytologically confirmed diagnosis of ES-SCLC.
- For Cohort 1, subject has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Cohort 2, subject has received no prior treatment for ES-SCLC.
You likely can't join if
- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, as explained in the study protocol.
- Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections.
- Has history of malignancy other than SCLC within the 3 years prior to randomization / enrolment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumours, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
- Has history of allogeneic bone marrow, stem cell, or solid organ transplant.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.
See the full eligibility criteria
Who can join
- Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures.
- A male subject capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each study drug. The length of time required to continue contraception and avoid donating sperm after last dose for I-DXd/atezolizumab/carboplatin is 6/5/6 months, respectively. a. Avoid donating sperm. Note: Preservation of sperm should be considered prior to enrolment / randomization in this trial. b. Adhere to either of the following contraception methods: i. True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject, OR ii. Uses a penile/external condom when having penile-vaginal intercourse with a non-subject of childbearing potential PLUS partner use of an additional contraceptive method, as a condom may break or leak. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study drugs are more stringent than the requirements above, the local label requirements are to be followed. Note: If the subject is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the subject’s medical records, medical examination, or medical history interview), no contraception is required.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Has histologically or cytologically confirmed diagnosis of ES-SCLC.
- For Cohort 1, subject has received 4 cycles of 1L induction therapy with carboplatin, etoposide, and atezolizumab for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Cohort 2, subject has received no prior treatment for ES-SCLC.
- For Cohort 2, subject has at least one measurable lesion according to RECIST v1.1 on CT or MRI as assessed by the investigator.
- For Cohort 2, subject must have at least one lesion, amenable to core biopsy, and must consent to provide a pretreatment biopsy tissue sample and on-treatment biopsy.
- Has ECOG PS of ≤1 (assessed within 7 days before enrollment/randomization).
- Has adequate organ and bone marrow function within 7 days before the start of study treatment as specified in the study protocol.
- A female subject of childbearing potential (POCBP), as defined in Section 10.3.4 of the Protocol, is eligible to participate if the following conditions are met: a. Subject is not pregnant as confirmed by highly sensitive pregnancy test during Screening (within 3 days prior to enrollment/randomization) b. Subject does not breastfeed during the treatment period and for at least 8/5/6 months after last dose of I-DXd/atezolizumab/carboplatin, respectively. c. Subject agrees to adhere to a contraceptive method that is highly effective (Section 10.3.4) and agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during the treatment period and for at least the time needed to eliminate each study drug after the last dose. The length of time required to continue contraception and avoid donating/freezing eggs after last dose for IDXd/atezolizumab/carboplatin is 8/5/6 months, respectively. Preservation of eggs may be considered prior to first dose of study drug.
What rules you out
- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, as explained in the study protocol.
- Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease, topical steroids (for mild skin conditions), or intra-articular steroid injections.
- Has history of malignancy other than SCLC within the 3 years prior to randomization / enrolment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal tract tumours, and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
- Has history of allogeneic bone marrow, stem cell, or solid organ transplant.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE V5.0, Grade ≤1 or baseline.
- Has history of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has active or uncontrolled HIV infection. Subjects must be tested for HIV viral load during the Screening Period if acceptable by local regulations or IRBs/IECs, as explained in the study protocol.
- Has active or uncontrolled hepatitis B or C infection. Hepatitis B and/or Hepatitis C screening tests are not required unless there is a known history of HBV infection or if mandated by local health authority. More details about subjects’ eligibility are explained in the study protocol.
- Has history of autoimmune disease, as explained in the study protocol.
- Prior discontinuation of an ADC that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
- Has any evidence of severe or uncontrolled systemic diseases, as included in the study protocol.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is a female who is pregnant or breastfeeding or planning to become pregnant.
- Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator’s opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.
- Has psychological, social, familial, or logistical factors that would prevent regular follow-up.
- Has received prior treatment with CD137 agonists or ICIs, including anti- cytotoxic T-cell lymphocyte-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, except for atezolizumab for Cohort 1.
- Has inadequate washout period before enrolment / randomization as specified in the study protocol.
- Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
- Has clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Has clinically significant corneal disease.
- Has uncontrolled or significant cardiovascular disease, as explained in the study protocol.
- Has history of (non-infectious) ILD/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.