A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab as Second or Third Line Treatment for Small Cell Lung Cancer

Who is this study for? Patients with Lung Cancer
What treatments are being studied? Atezolizumab+Temozolomide
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, 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. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

‣ NOTE: HIPAA authorization may be included in the informed consent or obtained separately

• Age \>= 18 years at the time of consent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration

• Have histologically or cytologically-documented diagnosis of extensive stage (i.e. metastatic and/or recurrent) small cell lung cancer and have progressed or recurred after platinum-based chemotherapy with immunotherapy. Eligible patients will be defined as follows:

‣ Sensitive Disease: Patients who had one previous line of chemotherapy and relapsed after \> 90 days of completion of treatment

⁃ Resistant Disease: Patients with no response to first-line chemo-immunotherapy or progression \< 90 days after completing treatment

• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to registration

• Maximum of 3 prior lines of systemic therapy is allowed in the setting of metastatic disease. Patients who recur after treatment for limited state disease, and who receive first line metastatic treatment with chemo-immunotherapy would be considered eligible upon progression on chemo-IO in the metastatic setting

• Absolute neutrophil count (ANC) \>= 1.5 K/mm\^3 (obtained within 28 days prior to registration)

• Platelets \>= 100,000 / mcL (obtained within 28 days prior to registration)

• Serum creatinine =\< 2.0 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 50 mL/min as estimated by Cockcroft and Gault formula for subject with creatinine levels \> 2 x institutional ULN (obtained within 28 days prior to registration)

• Bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN

‣ Patients with known Gilbert disease: serum bilirubin =\< 3 x ULN) (obtained within 28 days prior to registration)

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\< 3 X ULN OR =\< 5 X ULN for subjects with liver metastases (obtained within 28 days prior to registration)

• Albumin \> 2.5 g/dL (obtained within 28 days prior to registration)

• International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)

‣ For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

• Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)

‣ For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

• Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration

• For women of childbearing potential: agreement to remain abstinent (refrain from vaginal intercourse) or use contraceptive methods and agreement to refrain from donating eggs, as defined below:

‣ Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab or temozolomide. Women must refrain from donating eggs during this same period

⁃ Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices

⁃ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post ovulation methods) and withdrawal are not adequate methods of contraception

• For men able to father a child: agreement to remain abstinent (refrain from vaginal intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:

‣ With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 3 months after the final dose of temozolomide to avoid exposing the embryo. Men must refrain from donating sperm during this same period

⁃ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception

• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

• Availability of archival tissue, preferably a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening. Patients with tumor specimens older than 1 year, or who do not have biopsy specimen may still be eligible if deemed so by the sponsor-investigator.

• Be willing to provide peripheral blood samples at specified time-points during the study

• Life expectancy greater than 3 months as determined by the enrolling physician or protocol designee

• Ability to swallow and retain oral medication

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Illinois
University of Illinois Cancer Center
RECRUITING
Chicago
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Dwight Owen
dwight.owen@osumc.edu
614-685-2039
Backup
Amber Ryba
aryba@hoosiercancer.org
317-634-5842
Time Frame
Start Date: 2022-01-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 56
Treatments
Experimental: Cohort I (atezolizumab, temozolomide)
Patients receive atezolizumab IV over 30-60 minutes on day 1 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Cohort II (atezolizumab, temozolomide)
Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sponsors
Collaborators: Genentech, Inc.
Leads: Dwight Owen

This content was sourced from clinicaltrials.gov

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