Clinical trial · Interventional
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
NCT06709859CI-TRIAL-00092297recruitingPhase 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)
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
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 |
|---|---|---|---|
| Afatinib plus chemotherapy as conversion treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Afatinib plus chemotherapy
- description
- Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery.
- interventionNames
- Drug: Afatinib plus chemotherapy as conversion treatment
Primary outcomes (1)
- measure
- The rate of NSCLC converting to resectable tumors
- timeFrame
- Up to 12 weeks
- description
- The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator. * Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation * ECOG Performance Status of 0-1 * At least one measurable lesion according to RECIST 1.1 * Adequate organ and marrow function Exclusion Criteria: * Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma * The presence of malignant pleural effusion * Prior systemic anti-cancer therapy for non-small cell lung cancer * Prior local radiotherapy for NSCLC * Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
References
Publications (0)
Data not yet available
No reference posted for this study.