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LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Lung Small Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atezolizumab
Carboplatin
Etoposide
Protein Phosphatase 2A Inhibitor LB-100
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Lung Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma per the Veterans Administration Lung Study Group (VALG) staging system
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST guideline (version 1.1)
  • Estimated life expectancy of at least 12 weeks
  • For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea) or have a negative pregnancy test. Women of childbearing potential must be compliant with a medically approved contraceptive regimen (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 14 days before study drug treatment and must not be breastfeeding
  • For men: agreement to remain abstinent or use medically approved contraceptive measures, as defined below:

    • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during study therapy and for at least 6 months after the last dose of study therapy to avoid exposing the embryo
  • A performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 10/L
  • Platelets >= 100 x 10/L
  • Hemoglobin >= 9 g/dL
  • Bilirubin =< 1.5 times upper limits of normal (ULN) may be enrolled
  • Alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 times ULN (AP, AST, and ALT =< 5 times ULN are acceptable if the liver has tumor involvement)
  • Calculated creatinine clearance (CrCl) >= 60 mL/min based on the Cockcroft and Gault formula
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • No prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC

Exclusion Criteria:

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung cancer (SCLC)
  • No prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =< 6 = Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry
  • Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
  • Active or ongoing infection during screening requiring the use of systemic antibiotics
  • Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association class III or IV
  • Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug
  • Known or suspected allergy to any agent given in association with this trial
  • Pregnant or lactating women
  • History of autoimmune disease, including minor/mild autoimmune disease not requiring immunosuppressants (such as eczema on less than 10% of the body surface area and long term diabetes mellitus type 1 on stable insulin)
  • Known hepatitis B or hepatitis C
  • Known human immunodeficiency virus (HIV) positive
  • Treatment with systemic corticosteroid or other immunosuppressive medication. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed
  • Administration of a live, attenuated vaccine within 28 days prior to study
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed
  • Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN). Patients who are receiving denosumab prior to study entry must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • QTcF (Fridericia Correction Formula) > 470 on 2 out of 3 electrocardiograms (EKG's)
  • Diagnosis of congenital long QT syndrome
  • Treatment, within 7 days prior to first dose of study drug, with medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes
  • Treatment with CYP450 substrates within 7 days prior to first dose of study drug
  • Treatment with nephrotoxic compounds within 7 days prior to first dose of study drug
  • Treatment with warfarin within 7 days prior to first dose of study drug
  • Treatment with antiepileptic medications that may increase etoposide clearance (including but not limited to phenytoin, phenobarbital, carbamazepine, and valproic acid) within 7 days prior to first dose of study drug
  • Treatment with strong P-glycoprotein inhibitors within 7 days prior to first dose of study drug
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (LB-100, carboplatin, etoposide, atezolizumab)

Arm Description

INDUCTION: Patients receive LB-100 IV over 15 minutes on days 1 and 3, atezolizumab IV over 30-60 minutes on day 1, carboplatin IV over 30-60 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: After completion of induction therapy, patients receive LB-100 IV over 15 minutes on days 1 and 3 and atezolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Recommended phase II dose (RP2D)
Measured using dose-limiting toxicity (DLT) during the first cycle as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Outcome Measures

Objective response rate (ORR)
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Patients who respond to treatment and die without progressive disease (PD) (including death from study disease), duration of response will be censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have PD, duration of response will be censored at the last progression-free assessment date. For responding patients who receive subsequent anticancer therapy (after discontinuation from all study treatment excluding PCI) prior to disease progression, duration of response will be censored at the date of last progression-free assessment prior to the initiation of post discontinuation anticancer therapy.
Duration of overall response
Measured by RECIST v1.1.
Incidence of safety and adverse events
Assessed by CTCAE version 5.0.
Progression-free survival (PFS)
As defined by RECIST v1.1.
Overall survival (OS)
OS which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient's last contact (last contact for patients in post discontinuation is last known alive date in mortality status).

Full Information

First Posted
June 22, 2020
Last Updated
March 10, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04560972
Brief Title
LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer
Official Title
A Phase Ib Open-Label Study of LB-100 in Combination With Carboplatin/Etoposide/Atezolizumab in Untreated Extensive-Stage Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
March 9, 2026 (Anticipated)
Study Completion Date
March 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase Ib trial studies the side effects and best dose of LB-100 when given together with carboplatin, etoposide, and atezolizumab for the treatment of untreated extensive-stage small cell lung cancer. Drugs such as carboplatin and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. LB-100 has been shown to make anticancer drugs (chemotherapy) work better at killing cancer. LB-100 blocks a protein on the surface of cells called PP2A. Blocking this protein makes the tumor cells that express PP2A divide. This allows standard chemotherapy drugs such as carboplatin, etoposide, and atezolizumab work better at killing the tumor cells since these drugs work best at destroying cells that are dividing. Giving LB-100 in combination with standard chemotherapy drugs may work better to treat extensive-stage small cell lung cancer compared to standard chemotherapy drugs alone.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the recommended phase II dose (RP2D) of protein phosphatase 2A inhibitor LB-100 (LB-100) when given in combination with standard carboplatin/etoposide/atezolizumab in treatment naive patients with extensive-stage small cell lung cancer (ED-SCLC). SECONDARY OBJECTIVES: I. To assess objective response rate (ORR). II. To assess progression-free survival (PFS). III. To assess overall survival (OS). IV. To assess duration of overall response (DOR). V. To assess safety and adverse events (AEs). EXPLORATORY OBJECTIVES: I. The pharmacokinetics (PK) of LB-100 and etoposide. II. The biomarkers relevant to LB-100 and the disease state as well as their correlation to clinical outcomes. OUTLINE: This is a dose-escalation study of LB-100. INDUCTION: Patients receive LB-100 intravenously (IV) over 15 minutes on days 1 and 3, atezolizumab IV over 30-60 minutes on day 1, carboplatin IV over 30-60 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: After completion of induction therapy, patients receive LB-100 IV over 15 minutes on days 1 and 3 and atezolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 30 days, and patients who discontinue study treatment without disease progression are followed every 6-8 weeks thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Lung Small Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (LB-100, carboplatin, etoposide, atezolizumab)
Arm Type
Experimental
Arm Description
INDUCTION: Patients receive LB-100 IV over 15 minutes on days 1 and 3, atezolizumab IV over 30-60 minutes on day 1, carboplatin IV over 30-60 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: After completion of induction therapy, patients receive LB-100 IV over 15 minutes on days 1 and 3 and atezolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Protein Phosphatase 2A Inhibitor LB-100
Other Intervention Name(s)
LB-100, PP2A Inhibitor LB-100
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Recommended phase II dose (RP2D)
Description
Measured using dose-limiting toxicity (DLT) during the first cycle as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
End of first cycle (21 days)
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Patients who respond to treatment and die without progressive disease (PD) (including death from study disease), duration of response will be censored at the date of the last objective progression-free disease assessment. For responding patients not known to have died as of the data cut-off date and who do not have PD, duration of response will be censored at the last progression-free assessment date. For responding patients who receive subsequent anticancer therapy (after discontinuation from all study treatment excluding PCI) prior to disease progression, duration of response will be censored at the date of last progression-free assessment prior to the initiation of post discontinuation anticancer therapy.
Time Frame
Up to 2 years
Title
Duration of overall response
Description
Measured by RECIST v1.1.
Time Frame
Up to 2 years
Title
Incidence of safety and adverse events
Description
Assessed by CTCAE version 5.0.
Time Frame
Up to 2 years
Title
Progression-free survival (PFS)
Description
As defined by RECIST v1.1.
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
OS which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient's last contact (last contact for patients in post discontinuation is last known alive date in mortality status).
Time Frame
Time from the date of study enrollment to the date of death from any cause, assessed up to 2 years
Other Pre-specified Outcome Measures:
Title
Cmax of LB-100
Description
Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Cmax of LB-100.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
Cmax of endothall
Description
Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Cmax of endothall.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
Tmax of LB-100
Description
Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the Tmax of LB-100.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
Tmax of endothall
Description
Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the Tmax of endothall.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
t1/2 of LB-100
Description
Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the t1/2 of LB-100.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
t1/2 of endothall
Description
Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the t1/2 of endothall.
Time Frame
[Time Frame: Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
AUC0-t of LB-100
Description
Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the AUC0-t of LB-100.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
AUC0-t of endothall
Description
Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the AUC0-t of endothall.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
CL of LB-100
Description
Plasma sampling for pharmacokinetic (PK) measurements of LB-100 will be performed . Blood samples will be collected to determine the CL of LB-100.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
CL of endothall
Description
Plasma sampling for pharmacokinetic (PK) measurements of endothall, the metabolite of LB-100, will be performed . Blood samples will be collected to determine the CL of endothall.
Time Frame
Cycle 1 day 1: Pre-dose, immediately post LB-100 infusion, at 15 & 30 minutes, at 1, 2, 4, and 8 hours post LB-100 infusion (Each cycle is 21 days); Cycle 1, days 2-3: Pre-dose and 24 hours post LB-100 infusion (Each cycle is 21 days)]
Title
Relative abundance of immune cell populations
Description
The signaling states that evolve in immune cells during treatment and that differentiate responders from nonresponders. Number of effector memory T cells Number of classical monocytes
Time Frame
Up to 2 years]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma per the Veterans Administration Lung Study Group (VALG) staging system Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST guideline (version 1.1) Estimated life expectancy of at least 12 weeks For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea) or have a negative pregnancy test. Women of childbearing potential must be compliant with a medically approved contraceptive regimen (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 14 days before study drug treatment and must not be breastfeeding For men: agreement to remain abstinent or use medically approved contraceptive measures, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during study therapy and for at least 6 months after the last dose of study therapy to avoid exposing the embryo A performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 10/L Platelets >= 100 x 10/L Hemoglobin >= 9 g/dL Bilirubin =< 1.5 times upper limits of normal (ULN) may be enrolled Alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 times ULN (AP, AST, and ALT =< 5 times ULN are acceptable if the liver has tumor involvement) Calculated creatinine clearance (CrCl) >= 60 mL/min based on the Cockcroft and Gault formula All subjects must have the ability to understand and the willingness to sign a written informed consent No prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC Exclusion Criteria: Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung cancer (SCLC) No prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =< 6 = Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol Active or ongoing infection during screening requiring the use of systemic antibiotics Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association class III or IV Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug Known or suspected allergy to any agent given in association with this trial Pregnant or lactating women History of autoimmune disease, including minor/mild autoimmune disease not requiring immunosuppressants (such as eczema on less than 10% of the body surface area and long term diabetes mellitus type 1 on stable insulin) Known hepatitis B or hepatitis C Known human immunodeficiency virus (HIV) positive Treatment with systemic corticosteroid or other immunosuppressive medication. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed Administration of a live, attenuated vaccine within 28 days prior to study Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN). Patients who are receiving denosumab prior to study entry must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted Prior allogeneic bone marrow transplantation or solid organ transplant QTcF (Fridericia Correction Formula) > 470 on 2 out of 3 electrocardiograms (EKG's) Diagnosis of congenital long QT syndrome Treatment, within 7 days prior to first dose of study drug, with medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes Treatment with CYP450 substrates within 7 days prior to first dose of study drug Treatment with nephrotoxic compounds within 7 days prior to first dose of study drug Treatment with warfarin within 7 days prior to first dose of study drug Treatment with antiepileptic medications that may increase etoposide clearance (including but not limited to phenytoin, phenobarbital, carbamazepine, and valproic acid) within 7 days prior to first dose of study drug Treatment with strong P-glycoprotein inhibitors within 7 days prior to first dose of study drug Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Salgia
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Salgia
Phone
626-218-3712
Email
rsalgia@coh.org
First Name & Middle Initial & Last Name & Degree
Ravi Salgia

12. IPD Sharing Statement

Learn more about this trial

LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer

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