Clinical trial · Interventional
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
NCT03755102CI-TRIAL-00089762completedEarly Phase 1ClinicalTrials.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)
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacomitinib | Drug | — | UNRESOLVED |
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Participants treated with dacomitinib alone
- description
- Participants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.
- interventionNames
- Drug: Dacomitinib
- type
- EXPERIMENTAL
- label
- Cohort 2: Participants treated with dacomitinib in combination with osimertinib
- description
- Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation
- interventionNames
- Drug: Dacomitinib
- Drug: Osimertinib
Primary outcomes (1)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Advanced biopsy-proven metastatic non-small cell lung cancer * Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy * Prior treatment with osimertinib with response followed by disease progression * No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib) * Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation * Measurable (RECIST 1.1) indicator lesion not previously irradiated * Karnofsky performance status (KPS) \>/= 70% * Age \>/= 18 years old * Ability to swallow oral medication * Adequate organ function * AST, ALT \</= 3 x ULN * Total bilirubin \</= 1.5x ULN * Creatinine \</= 1.5x ULN OR calculated creatinine clearance \>/= 60ml/min * Absolute neutrophil count (ANC) \>/= 1000 cells/mm3 * Hemoglobin\>/=8.0 g/dL * Platelets \>/=75,000/mm3 Exclusion Criteria: * Pregnant or lactating women * Any radiotherapy within 1 week of starting treatment on protocol. * Any major surgery within 1 weeks of starting treatment on protocol. * Any evidence of active clinically significant interstitial lung disease * Continue to have unresolved \> grade 1 toxicity from any previous treatment Treatment * Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion). * Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids
References
Publications (0)
Data not yet available
No reference posted for this study.