OncoMatch/Clinical Trials/NCT02998567
Combination Study of Guadecitabine/ASTX727 and Pembrolizumab
Is NCT02998567 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Guadecitabine and Pembrolizumab for non small cell lung cancer.
Treatment: Guadecitabine · Pembrolizumab · ASTX727 — HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage IV
evaluable or measurable disease as assessed by RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy — advanced or metastatic disease
NSCLC previously treated with PD-1 or PD-L1 inhibitor for advanced or metastatic disease
Cannot have received: radiotherapy
Exception: brief course for palliative reasons
Radiotherapy (except brief course for palliative reasons)...during the previous four weeks
Cannot have received: endocrine therapy
Exception: hormonal therapy with LHRH analogues for medical castration in patients with CRPC, which are permitted
endocrine therapy...during the previous four weeks...except for hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with CRPC, which are permitted
Cannot have received: immunotherapy
immunotherapy...during the previous four weeks
Cannot have received: chemotherapy
chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C and 4 weeks for investigational medicinal products) before treatment
Lab requirements
Blood counts
Haemoglobin (Hb) ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; INR ≤ 1.5x ULN or prothrombin time ≤ 1.5x ULN
Kidney function
Calculated creatinine clearance (per institutional standard) ≥ 50 mL/min
Liver function
Serum bilirubin ≤1.5x ULN or direct bilirubin (for patients with total bilirubin >1.5x ULN) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (for patients with liver metastases ≤ 5x ULN is permissible)
Cardiac function
Mean resting QTc > 470 msec (excluded); significant ECG abnormalities; risk factors for QTc prolongation or arrhythmic events; LVEF below institutional lower limit of normal; uncontrolled hypertension (Systolic BP >160mmHg and/or diastolic BP >100mmHg)
Haematological and biochemical indices within the ranges shown below...cardiac criteria: Mean resting QTc > 470 msec...LVEF below institutional lower limit of normal...uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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