Clinical trial · Interventional
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed due to low enrollment
Summary
Brief summary (as posted)
This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
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 |
|---|---|---|---|
| Metastatic Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.
- interventionNames
- Drug: nimotuzumab
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- A placebo will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.
- interventionNames
- Drug: nimotuzumab
Primary outcomes (1)
- measure
- Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Providing a written informed consent (see Appendix A); * Age ≥18 years; * Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other); * At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain; * Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration * KPS ≥70; * Absolute neutrophil count ≥ 1500/mm³; * Platelet count ≥ 50,000/mm³; * Serum creatinine ≤2.0 mg/dL; * Serum transaminases ≤2 x the upper limit of normal (ULN); * Total serum bilirubin ≤2 x ULN; * And a lactate dehydrogenase (LDH) level ≤1.3 x ULN. Exclusion Criteria: * Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception); * Prior WBRT, brain metastases resection with no other measurable lesion remaining; * Extracranial metastases in two or more organs; * Known leptomeningeal or subarachnoid tumor spread; * Plan to use radiosurgery or radiation boost after completion of WBRT; * Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT; * Previous use of an anti-EGFR drug; * Participation in another ongoing therapeutic trial; * Presence of known HIV seropositivity, severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix); * Hypersensitivity or allergy to any of the drugs to be administered in this study; * Inability or unwillingness to complete the required assessments; * Geographic inaccessibility for treatment or follow-up evaluations.
References
Publications (0)
Data not yet available