Clinical trial · Interventional
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
NCT00548093CI-TRIAL-00038718completedPhase 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)
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
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 |
|---|---|---|---|
| Carcinoma, Non Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-00299804 | Drug | Dacomitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- descriptive: adenocarcinoma histology
- interventionNames
- Drug: PF-00299804
- type
- EXPERIMENTAL
- label
- 2
- description
- descriptive: non-adenocarcinoma histology
- interventionNames
- Drug: PF-00299804
Primary outcomes (1)
- measure
- Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
- timeFrame
- Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced Non-Small Cell Lung Cancer (NSCLC) * Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib. * Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment. * Measurable disease . * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Tissue available for KRAS/ EGFR testing * Creatinine clearance \> 40 cc/min or serum creat \< 1.5 x ULN Exclusion Criteria: * Chemotherapy * Radiotherapy * Biological or investigational agents within 4 weeks of baseline disease assessment. * Patients who lack of tolerance of erlotinib therapy.
References
Publications (1)
- DERIVEDReckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Janne PA. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5. PMID 24501009