OncoMatch/Clinical Trials/NCT04919382
Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
Is NCT04919382 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Temozolomide for extensive stage lung small cell carcinoma.
Treatment: Atezolizumab · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IV, IVA, IVB (AJCC v8)
Metastatic disease required
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to registration
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — with immunotherapy
have progressed or recurred after platinum-based chemotherapy with immunotherapy
Cannot have received: temozolomide (temozolomide)
Has received prior temozolomide therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1.5 K/mm^3; Platelets >= 100,000 / mcL; INR or prothrombin time (PT) <= 1.5 x ULN for patients not receiving therapeutic anticoagulation; For patients receiving therapeutic anticoagulation: stable anticoagulant regimen; Activated partial thromboplastin time (aPTT) <= 1.5 x ULN for patients not receiving therapeutic anticoagulation; For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Kidney function
Serum creatinine <= 2.0 x ULN OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance) >= 50 mL/min as estimated by Cockcroft and Gault formula for subject with creatinine levels > 2 x institutional ULN
Liver function
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; AST and ALT <= 3 x ULN OR <= 5 x ULN for subjects with liver metastases; Albumin > 2.5 g/dL
Absolute neutrophil count (ANC) >= 1.5 K/mm^3... Platelets >= 100,000 / mcL... 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... 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)... Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 3 X ULN OR <= 5 X ULN for subjects with liver metastases... Albumin > 2.5 g/dL... INR or prothrombin time (PT) <= 1.5 x ULN for patients not receiving therapeutic anticoagulation... For patients receiving therapeutic anticoagulation: stable anticoagulant regimen... Activated partial thromboplastin time (aPTT) <= 1.5 x ULN for patients not receiving therapeutic anticoagulation... For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois Cancer Center · Chicago, Illinois
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- University of Wisconsin · Madison, Wisconsin
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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