Study of Carboplatin, Etoposide, and Atezolizumab With or WithoutTrilaciclib (G1T28) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

Phase 1

Conditions: ntreated Extensive-Stage Small Cell Lung Cancer
MedDRA version: 20.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000358-20-FR

Lead Sponsor: G1 Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must
apply.
1. Age = 18 years
2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably
including the presence of neuroendocrine features by immunohistochemistry
3. Extensive-stage SCLC
4. At least 1 target lesion that is measurable by RECIST v1.1 (Eisenhauer 2009)
5. Hemoglobin = 9.0 g/dL
6. Absolute neutrophil count (ANC) = 1.5 × 109/L
7. Platelet count = 100 × 109/L
8. Creatinine = 1.5 mg/dL or glomerular filtration rate (GFR) of = 60 mL/minute
9. Total bilirubin = 1.5 × ULN; < 3 × ULN if the patient has documented Gilbert’s disease
10. AST and ALT = 2.5 × ULN; = 5 × ULN in the presence of liver metastases
11. ECOG performance status of 0 to 2
12. Predicted life expectancy of = 3 months
13. Contraception:
a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) test result at screening and at baseline. Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception. Menopause is defined as 12 months of amenorrhea in a woman over the age of 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone (FSH) level > 40 mIU/mL to confirm menopause. Females treated with hormone replacement therapy (HRT) are likely to have artificially suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH level. If the serum FSH level is > 40 mIU/mL at any time during the washout period, the woman can be considered postmenopausal. Acceptable surgical sterilization techniques are
hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy, with surgery at least 2 months prior to dosing. Acceptable methods of contraception are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), a vasectomized partner, and a barrier method (condom or diaphragm) during the study and for 6
months after discontinuation of treatment
b. For males: Patients with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected, or implanted hormonal methods of contraception or an intrauterine device/system by the female partner, in combination with a barrier method (eg, condom, diaphragm, cervical cap) during the study and for 6 months after discontinuation of treatment, and will also refrain from sperm donation for 6 months following completion of the study
14. Able to understand and sign an informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria
apply.
1. Limited-stage SCLC
2. Prior chemotherapy for limited or extensive-stage SCLC
3. Prior treatment with immunotherapies including but not limited to cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies (such as anti-PD-1, anti-PD-L1, CTLA4 therapeutic antibodies)
4. Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids
5. Malignancies other than SCLC within 3 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan (history of radiation pneumonitis in the radiation field [fibrosis] is permitted)
7. Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Exceptions include vitiligo, controlled asthma, type I diabetes, Graves’ disease, Hashimoto’s disease, or with medical monitor approval. Stable replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) for well-controlled disease is not
considered a form of systemic treatment.
8. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
(Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
9. Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
10. Serious active infection at the time of enrollment
11. Psychiatric illness/social situations that would limit study compliance
12. Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion
could affect compliance or follow-up in the protocol
13. Known human immunodeficiency virus (HIV), known active Hepatitis B (eg, HBsAg
reactive or HBV DNA detected) or Hepatitis C (eg, HCV RNA [qualitative] is detected)
14. Radiotherapy to any site within 2 weeks prior to enrollment
15. Receipt of any investigational medication within 4 weeks prior to enrollment
16. Administration of a live attenuated vaccine within 4 weeks before enrollment or anticipation that such a live attenuated vaccine will be required during the study
17. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (eg, FluMist) within 4 weeks prior to enrollment, at any time during the study, and at least 5 months after the last dose of atezolizumab
18. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide,
and anti-tumor necrosis factor [TNF] agents) within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
19. Hypersensitivity to any of the components of the formulation of etoposide or etoposide phosphate
20. Hypersensitivity to carboplatin or

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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