Full Title
A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7-H3 Antibody-Drug Conjugate (ADC), in Combination with Atezolizumab with or without Carboplatin as First-line Induction or Maintenance, in Subjects with Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)Purpose
Researchers want to learn if a combination of anti-cancer medications is safe for people with small cell lung cancer (SCLC). The people in this study have SCLC that has metastasized (spread). They will get ifinatamab deruxtecan (I-DXd) and atezolizumab immunotherapy, with or without carboplatin chemotherapy.
I-DXd is a type of drug called an antibody-drug conjugate (ADC). ADCs are made of a monoclonal antibody linked to a drug. The antibody binds to a protein on cancer cells called B7-H3, which plays a role in cancer cell growth. It then releases the anti-cancer drug to kill the cancer cell. By destroying these cells, I-DXd may help slow or stop the growth of your cancer.
Atezolizumab is a drug that boosts the power of your immune system to find and kill cancer cells. Carboplatin is a standard chemotherapy drug. All of the medications in this study are given intravenously (by vein).
If you join this study, you will be in one of these groups:
- Group 1 will have already received induction therapy (carboplatin, etoposide, and atezolizumab) before enrolling in this study. As part of this study, they will receive I-DXd and atezolizumab (maintenance therapy).
- Group 2 will receive 4 cycles of I-DXd, atezolizumab, and carboplatin (induction therapy), followed by I-DXd and atezolizumab (maintenance therapy).
Who Can Join
To join this study, there are a few conditions. You must:
- Have metastatic (stage 4) extensive-stage SCLC.
- Have recovered from the serious side effects of prior treatments before getting the study therapy.
- Not have received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd; CD137 agonists; or immunotherapy.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Charles Rudin’s office at 646-608-3788.