Clinical trial · Interventional
A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer
Phase 2 Open Label Trial Of Oral Intermittent Dacomitinib In Patients With Advanced Nsclc
NCT01858389CI-TRIAL-00028664completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 2 study of oral dacomitinib given every 12 hours over days 1-4 of each two-week cycle to patients with Non-small cell lung cancer. The study includes two groups of patients, those whose tumor has a documented T790M mutation, and those without this mutation. All patients will receive repeated cycles of dacomitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacomitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor.
- interventionNames
- Drug: Dacomitinib
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations.
- interventionNames
- Drug: Dacomitinib
Primary outcomes (2)
- measure
- Best Overall Response (BOR) in Participants With T790M Mutation
- timeFrame
- From baseline until disease progression, up to 61 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of histologically confirmed, advanced NSCLC (stage IIIB/IV). * Evidence of T790M mutation to enroll in Cohort A. * Evidence of measurable disease by radiographic technique. * Adequate organ function. Exclusion Criteria: * Patients with T790M mutation who stopped any prior EGFR-directed therapy without evidence of disease progression. * Symptomatic brain metastases. * Uncontrolled or significant cardiovascular disease. * Pregnant or breastfeeding.
References
Publications (2)
- DERIVEDTan W, Giri N, Quinn S, Wilner K, Parivar K. Evaluation of the potential effect of dacomitinib, an EGFR tyrosine kinase inhibitor, on ECG parameters in patients with advanced non-small cell lung cancer. Invest New Drugs. 2020 Jun;38(3):874-884. doi: 10.1007/s10637-019-00887-0. Epub 2019 Dec 19. PMID 31858327
- DERIVEDYu HA, Ahn MJ, Cho BC, Gerber DE, Natale RB, Socinski MA, Giri N, Quinn S, Sbar E, Zhang H, Giaccone G. Phase 2 study of intermittent pulse dacomitinib in patients with advanced non-small cell lung cancers. Lung Cancer. 2017 Oct;112:195-199. doi: 10.1016/j.lungcan.2017.08.017. Epub 2017 Aug 23. PMID 29191595