Clinical trial · Interventional
Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
NCT02064491CI-TRIAL-00028214completedPhase 2ClinicalTrials.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 determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib and Chemotherapy
- description
- Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
- interventionNames
- Drug: Erlotinib
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Chemotherapy for four to six cycles
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Progression-free survival of the whole study population and in the strata 1-2
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IIIB/IV NSCLC. * Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization * Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months * Performance status: WHO 0-2 * Measurable disease according to RECIST 1.1 * Patients must be able to comply with study treatments * Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study * Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (\< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN. * Patient must be able to comply with the protocol Exclusion Criteria: * RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment. * Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment. * Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib. * Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study. * Patient with symptomatic central nervous system metastases * Patient has known active hepatitis B or C, or HIV infection * Pregnant or breastfeeding. * Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
References
Publications (0)
Data not yet available
No reference posted for this study.