Clinical trial · Interventional
Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC
Efficacy and Safety of Afatinib in Patients With EGFR-mutated Metastatic Non-small-cell Lung Cancer Previously Responsive to First-generation Tyrosine-kinase Inhibitors and Chemotherapy
- 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 investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Afatinib
- description
- Afatinib 30 or 40 or 50mg daily orally after study recruitment until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.
- interventionNames
- Drug: Afatinib
- Drug: Erlotinib
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Erlotinib 150mg daily until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.
- interventionNames
- Drug: Afatinib
- Drug: Erlotinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy * Adequate hematological function (ANC \>=1.5 x 10\^9/l, Hb \>=9.0 x 10\^9/l, plt \>=100 x 10\^9/l) * Adequate renal function (with estimated creatinine clearance \>=50ml/min as determined by Cockcroft-Gault formula) * Adequate liver function (ALT/AST \<2.5 x upper normal limit or ALT/AST \<5 x upper normal limit in the presence of liver metastasis) * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Evaluable target lesions according to RECIST 1.1 for tumour response assessment * Patients able to give written consent Exclusion Criteria: * Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication * Significant cardiovascular abnormalities * Significant psychiatric disorders * Patients who have documented history of interstitial lung disease
References
Publications (1)
- DERIVEDLee VH, Leung DK, Choy TS, Lam KO, Lam PM, Leung TW, Kwong DL. Efficacy and safety of afatinib in Chinese patients with EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) previously responsive to first-generation tyrosine-kinase inhibitors (TKI) and chemotherapy: comparison with historical cohort using erlotinib. BMC Cancer. 2016 Feb 24;16:147. doi: 10.1186/s12885-016-2201-9. PMID 26911310