OncoMatch/Clinical Trials/NCT06616623
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Is NCT06616623 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Atezolizumab and Vismodegib for metastatic lung non-small cell carcinoma.
Treatment: Atezolizumab · Vismodegib — This phase Ib trial tests the safety, side effects, and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or has spread from where it first started (primary site) to other places in the body (metastatic). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 a combination of vismodegib and atezolizumab may be safe, tolerable and/or effective than either drug alone in treating patients with recurrent or metastatic NSCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Allowed: ALK actionable mutation
Allowed: EGFR actionable mutation
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options; Measurable disease based on RECIST v1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy.
Must have received: immunotherapy
Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy.
Must have received: EGFR tyrosine kinase inhibitor (osimertinib) — adenocarcinoma with EGFR actionable mutation
Patients with adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all approved and standard of care treatment options (i.e. osimertinib for epidermal growth factor receptor (EGFR), alectinib for anaplastic lymphoma kinase (ALK), etc.)
Must have received: ALK inhibitor (alectinib) — adenocarcinoma with ALK actionable mutation
Patients with adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all approved and standard of care treatment options (i.e. osimertinib for epidermal growth factor receptor (EGFR), alectinib for anaplastic lymphoma kinase (ALK), etc.)
Lab requirements
Blood counts
ANC ≥ 1,500 /mcL without G-CSF support; platelet count ≥ 100,000 /uL without transfusion; hemoglobin ≥ 90 g/L (9 g/dL), patients may be transfused to meet this criterion
Kidney function
Measured or calculated creatinine clearance ≥ 60 mL/min for subjects with creatinine ≤ 1.5 x ULN
Liver function
Serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if Gilbert disease); direct bilirubin ≤ ULN if total bilirubin > 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); ALP ≤ 2.5 x ULN (≤ 5 x ULN with liver or bone metastases); albumin ≥ 2.5 g/dL
ANC ≥ 1,500 /mcL without granulocyte colony-stimulating factor support; Platelet count ≥ 100,000 /uL without transfusion; Hemoglobin ≥ 90 g/L (9 g/dL) patients may be transfused to meet this criterion; Measured or calculated creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min for subject with creatinine levels ≤ 1.5 x institutional upper limit of normal (ULN); Serum total bilirubin ≤ 1.5 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN; Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST/ALT ≤ 2.5 x ULN with the following exceptions: Patients with documented liver metastases: AST and ALT ≤ 5 x ULN; Both values must be in the specified range; Alkaline phosphatase (ALP) ≤ 2.5 x ULN with the following exceptions: Patients with documented liver or bone metastases: ALP ≤ 5 x ULN; Albumin ≥ 2.5 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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