Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Tarceva for Brain Metastases in NSCLC | 11.8 | 7.4 – 19.1 |
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Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer
Phase 2 trial testing Tarceva (Erlotinib hydrochloride) in Non-small Cell Lung Cancer in 44 participants. Completed in 4 December 2019.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 26 March 2009 |
| Primary completion | 4 December 2019 |
| Estimated completion | 4 December 2019 |
| Sites | 2 locations across United States |
M.D. Anderson Cancer Center — full company profile →
Adults 18 to 70, any sex, with Non-small Cell Lung Cancer or Brain Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Tarceva for Brain Metastases in NSCLC | 11.8 | 7.4 – 19.1 |
Overall Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle. The participants overall survival measured at 6 month, 1-year and 2 years.
| Group | Value | 95% CI |
|---|---|---|
| Phase II Tarceva for Brain Metastases in NSCLC | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Tarceva for Brain Metastases in NSCLC | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II Tarceva for Brain Metastases in NSCLC | 7 |
Time frame: From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase II Tarceva for Brain… |
|---|---|---|
| Acne Rash | Skin and subcutaneous tissue disorders | — |
| Dehydration | Gastrointestinal disorders | — |
| Fatigue | Congenital, familial and genetic disorders | — |
| Dyspenea | Respiratory, thoracic and mediastinal disorders | — |
| Weakness | Musculoskeletal and connective tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Increased AST/ALT | Hepatobiliary disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Upper GI Bleed | Gastrointestinal disorders | — |
| Increased bilirubin | Hepatobiliary disorders | — |
| Headache | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspepsia | Respiratory, thoracic and mediastinal disorders | — |
| Weight Loss | Investigations | — |
Most-reported serious reactions: Acne Rash, Dehydration, Fatigue, Dyspenea, Weakness, Diarrhea, Pulmonary Embolism, Pleural Effusion.
Data from ClinicalTrials.gov NCT00871923 adverse events section.
The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).
2 peer-reviewed publications reference this trial (live from Europe PMC):
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