A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer.
Primary Objective:
To evaluate the safety, tolerability, and determine the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of tarlatamab in combination with programmed death ligand 1 (PD-L1) inhibition with or without chemotherapy.
Secondary Objectives:
To evaluate the 6-month progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control, and overall survival (OS) of tarlatamab in combination with PD-L1 inhibition and chemotherapy.
To characterize the pharmacokinetics (PK) of tarlatamab combination with PD-L1 inhibition with or without
chemotherapy.
Atezolizumab (MPDL3280A)
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Missak Haigentz MD
- Principal Investigator
Inclusion Criteria
- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed
consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer
(ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they
meet defined criteria.
- Adequate organ function as defined in protocol.
Exclusion Criteria
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or
life-threatening immune-mediated adverse events or infusion-related reactions
including those that lead to permanent discontinuation while on treatment with
immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious
pneumonitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
treatment.
- Participants with symptoms and/or clinical signs and/or radiographic signs that
indicate an acute and/or uncontrolled active systemic infection within 7 days prior to
the first dose of study treatment
- Participant has known active infection requiring parenteral antibiotic treatment. Upon
completion of parenteral antibiotics and resolution of symptoms, the participant may
be considered eligible for the study from an infection standpoint
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are
permitted if responding to an active treatment and after consultation with Medical
Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours,
have no leukocytosis, nor clinical signs of infection are eligible. Screening for
chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell
transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement
therapy) within the past 2 years or any other diseases requiring immunosuppressive
therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo-
or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.