OncoMatch/Clinical Trials/NCT04499053
Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer
Is NCT04499053 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Tremelimumab for carcinoma, non-small cell lung.
Treatment: Durvalumab · Tremelimumab — This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR ex19del
Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) ... excluded
Excluded: EGFR L858R
Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) ... excluded
Excluded: EGFR G719X
Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) ... excluded
Excluded: EGFR L861Q
Sensitizing EGFR mutations (deletion in exon 19, L858R in exon 21, G719X, and L861Q) ... excluded
Excluded: ALK translocation
and/or ALK translocations ... excluded
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
no previous systemic therapy for stage IV disease
Cannot have received: anti-PD-1 therapy
Exception: within 12 months of the first dose of durvalumab
Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 within 12 months of the first dose of durvalumab
Cannot have received: anti-PD-L1 therapy
Exception: within 12 months of the first dose of durvalumab
Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 within 12 months of the first dose of durvalumab
Cannot have received: anti-CTLA-4 therapy
Exception: within 12 months of the first dose of durvalumab
Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 within 12 months of the first dose of durvalumab
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000 per mm3; Platelet count ≥ 100,000 per mm3; CD4 T-cell count ≥ 100 per mm3 for HIV-infected patients
Kidney function
Measured or calculated creatinine clearance >40 mL/min (Cockcroft-Gault or 24-hour urine collection)
Liver function
Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases present, then ≤5x ULN
Adequate normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000 per mm3; Platelet count ≥ 100,000 per mm3; CD4 T-cell count ≥ 100 per mm3 for HIV-infected patients; Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)... AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN; Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
- Medstar Washington Hospital Center · Washington D.C., District of Columbia
- Marlene and Stewart Greenebaum Comprehensive Cancer Center · Baltimore, Maryland
- Harry and Jeannette Weinberg Cancer Institute at Franklin Square · Baltimore, Maryland
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