Phase 2 Study of Dacomitinib in NSCLC (NCT04027647) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Study of Dacomitinib in NSCLC
Hong Kong, Malaysia, Singapore118 participantsStarted 2019-09-11
Plain-language summary
This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC).
National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least one target lesion that has not previously been radiated, and is measurable according to RECIST v1.1;
✓. Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of positron emission tomography (PET)/CT, ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers;
✓. Estimated creatinine clearance ≥30 mL/min (as determined by Cockcroft-Gault formula or the study site's standard formula);
✓. AST (also known as SGOT) and ALT (also known as SGPT) ≤2.5 x ULN (≤5.0 x ULN if hepatic metastases).
Exclusion criteria
✕. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease;
✕. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline;
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From the start of treatment to the date of disease progression or death due to any cause at 12 months
✕. Insufficient lung function as determined by either clinical examination or an arterial oxygen tension of \<70 Torr.
✕. Diagnosed or suspected congenital long QT syndrome;
✕. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
✕. Prolonged QTc interval on ECG; QTc must be less than CTCAE v5.0 Grade 2 (≤480 msec) using Fridericia's or Bazett's correction formula with a manual reading by the investigator if required. The ECG may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation;
✕. Any history of second or third degree heart block;
✕. Heart rate \<45 beats per minute on ECG in the presence of clinical symptoms (e.g., hypotension, evidence of hypoperfusion);