Clinical trial · Interventional
A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed due to slow accrual.
Summary
Brief summary (as posted)
This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment. The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
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 |
|---|---|---|---|
| External radiotherapy | Procedure | — | UNRESOLVED |
| nimotuzumab | Biological | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 200 mg dose
- interventionNames
- Procedure: External radiotherapy
- Biological: nimotuzumab
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Procedure: External radiotherapy
- Biological: nimotuzumab
Primary outcomes (1)
- measure
- Phase II: Overall survival
- timeFrame
- Every 8 weeks until disease progression
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Patients must have histologically or cytologically confirmed non-small cell lung cancer. 2. Patients must be suitable for palliative radiation therapy as per institutional standards. 3. Stage IIB, III or IV (patients off steroids with treated, stable brain metastases are eligible). 4. Patients may be symptomatic or asymptomatic from disease 5. Age \>18 years 6. ECOG 0-1-2 7. Patients who received previous chemotherapy are allowed 8. Haemoglobin \>9g/dL (blood transfusion to increase Hb level is acceptable) 9. Stage II/III patients must be considered unsuitable for radical (standard full dose curative intent) chemoradiation in the opinion of either the radiotherapist or medical oncologist. 10. Patients must have measurable disease in the planned radiation field. 11. Women of child-bearing potential and men must agree to use adequate contraception. 12. Ability to understand and the willingness to sign a written informed consent document Exclusion criteria - Phase I and Phase II: 1. Patients receiving any other investigational agents 2. Previous treatment with anti-EGF-R drug(s) 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study. 4. Prior thoracic radiotherapy for this condition 5. Prior chemotherapy within 4 weeks of enrolment 6. Lesions not suitable for radiotherapy 7. Patients with known sero positive HIV 8. Patients with uncontrolled hypercalcemia 9. Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids 10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator 11. Pregnant or breast-feeding women 12. Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; patients with other prior malignancies are eligible providing prior malignancy cannot be clinically confused with the diagnosis of NSCLC in the opinion of the treating oncologist; in particular, there should be no evidence of current disease activity with respect to the prior malignancy 13. Life expectancy of less than 8 weeks
References
Publications (0)
Data not yet available