Clinical trial · Interventional
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation
- 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 current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Icotinib | Drug | Icotinib | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Thoracic radiotherapy(TRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Icotinib with concurrent radiotherapy
- description
- Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Icotinib
- Radiation: Thoracic radiotherapy(TRT)
- type
- ACTIVE_COMPARATOR
- label
- Chemoradiotherapy
- description
- Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity .
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin
- Radiation: Thoracic radiotherapy(TRT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation. 2. No previous systemic anticancer therapy. 3. life expectancy more than three months. 4. ECOG Performance Status of 0 to 1. 5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. 6. Patients will be required to provide informed consent before enrollment. Exclusion Criteria: 1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis. 2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway. 3. Severe heart disease, uncontrolled diabetes mellitus, or active infection. 4. Active concomitant malignancy, and pregnancy or breast-feeding.
References
Publications (0)
Data not yet available