Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer
2 other identifiers
interventional
56
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2022
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
April 8, 2026
April 1, 2026
5.9 years
June 3, 2021
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Investigator-assessed objective response rate (ORR)
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be defined by a confirmed complete response (CR) or confirmed partial response (PR). Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. ORR rate will be calculated as the proportion of patients with RECIST-based PR or CR divided by the total number of evaluable patients. Exact binomial 90% and 95% confidence intervals for the true PR+CR response rate will be calculated.
Up to 2 years
Secondary Outcomes (4)
Treatment related adverse events
Up to 2 years
Progression free survival (PFS)
From initiation of investigational therapy until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause, assessed up to 2 years
Intracranial PFS
At 6 months from start of investigational therapy
Overall survival
Date of initiation of investigational therapy to date of death from any cause, assessed up to 2 years
Study Arms (2)
Cohort I (atezolizumab, temozolomide)
EXPERIMENTALPatients 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.
Cohort II (atezolizumab, temozolomide)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- 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)
- +18 more criteria
You may not qualify if:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Has received prior temozolomide therapy
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
- Symptomatic central nervous system (CNS) metastases or untreated or actively progressing CNS metastases. Subjects with asymptomatic CNS metastases (treated or untreated) will be eligible provided all of the following criteria are met.
- Measurable disease, per RECIST v1.1, must be present outside the CNS.
- The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
- The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
- The patient has no ongoing requirement for corticosteroids as therapy for CNS disease at the time of study treatment.
- If the patient is receiving anti-convulsant therapy, the dose is considered stable and appropriate by the treating physician.
- Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
- NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases
- NOTE: A subject with previously treated brain metastasis may be considered if they have completed their treatment for brain metastasis at least 2 weeks prior to study registration and all of the above criteria are met.
- Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:
- Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice)
- Hepatitis B (known positive HBV surface antigen \[HBsAg\] result)
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dwight Owenlead
- Genentech, Inc.collaborator
Study Sites (5)
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dwight Owen
Ohio State University Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor Investigator
Study Record Dates
First Submitted
June 3, 2021
First Posted
June 9, 2021
Study Start
January 26, 2022
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04