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NCT01516983
A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.
Phase 1/Phase 2 trial testing icotinib in Non-small Cell Lung Cancer in 15 participants. Completed in 1 December 2013.
1 June 2013
Quick facts
| Lead sponsor | Betta Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 December 2011 |
| Primary completion | 1 June 2013 |
| Estimated completion | 1 December 2013 |
| Sites | 1 location across China |
Drugs / interventions tested
- icotinib — full drug profile →
- Whole brain radiotherapy
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- Brain Metastases — all drugs for Brain Metastases →
Sponsor
Betta Pharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-small Cell Lung Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability
Time frame: 6-12 months
All cause adverse events (AEs) and serious adverse events (SAEs)
Sponsor's own description
The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Effects of icotinib with and without radiation therapy on patients with EGFR mutant non-small cell lung cancer and brain metastases.
Fan Y, Xu Y, Gong L, Fang L, et al · · 2017 · cited 30× · PMID 28332624 · DOI 10.1038/srep45193 -
Brain metastasis: new opportunities to tackle therapeutic resistance.
Seoane J, De Mattos-Arruda L. · · 2014 · cited 30× · PMID 24953014 · DOI 10.1016/j.molonc.2014.05.009 -
Toward precision medicine with next-generation EGFR inhibitors in non-small-cell lung cancer.
Yap TA, Popat S. · · 2014 · cited 28× · PMID 25278773 · DOI 10.2147/pgpm.s55339 -
Efficacy and safety of therapies for EGFR-mutant non-small cell lung cancer with brain metastasis: an evidence-based Bayesian network pooled study of multivariable survival analyses.
Zhao B, Wang Y, Wang Y, Chen W, et al · · 2020 · cited 24× · PMID 32669477 · DOI 10.18632/aging.103455 -
Novel small molecule EGFR inhibitors as candidate drugs in non-small cell lung cancer.
Berardi R, Santoni M, Morgese F, Ballatore Z, et al · · 2013 · cited 16× · PMID 23723712 · DOI 10.2147/ott.s28155 -
Therapeutic Monitoring of Orally Administered, Small-Molecule Anticancer Medications with Tumor-Specific Cellular Protein Targets in Peripheral Fluid Spaces-A Review.
Köllő Z, Garami M, Vincze I, Vásárhelyi B, et al · · 2023 · cited 1× · PMID 36678867 · DOI 10.3390/pharmaceutics15010239
Verify or expand the search:
- PubMed search for NCT01516983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Betta Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT07435038 — Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS · Phase 1, PHASE2 · not yet recruiting
- NCT07448116 — Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. · Phase 1, PHASE2 · recruiting
- NCT06641609 — A Phase I Study of CFT8919 in Patients With Advanced NSCLC · Phase 1 · not yet recruiting
- NCT06015568 — Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive · Phase 1 · not yet recruiting
- NCT05869240 — BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors · Phase 1, PHASE2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01516983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Betta Pharmaceuticals Co., Ltd.
- Last refreshed: 13 February 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01516983.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing