Clinical trial · Interventional
Erlotinib and Sunitinib in NSCLC
Phase I Study of Erlotinib and Sunitinib in Non-small Cell Lung Cancer
NCT00581789CI-TRIAL-00041773completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
* To determine the safety and maximally tolerated dose of sunitinib plus erlotinib in patients with non-small cell lung cancer (NSCLC). * To determine response to sunitinib plus erlotinib in patients with non-small cell lung cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib, sunitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Erlotinib 150mg PO daily + sunitinib 25mg PO daily (level 1) or 37.5mg PO daily (level 2)
- interventionNames
- Drug: erlotinib, sunitinib
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven stage IIIB (with pleural effusion or pericardial effusion) or IV (either primary or recurrent) NSCLC (except squamous cell histology). * Measurable disease per RECIST * Life expectancy of at least 12 weeks. * Adequate bone marrow, hepatic and renal function * ECOG performance status 0, 1 or 2. * One and only one prior treatment with a chemotherapy regimen, including a platinum based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV). * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. * Female patients must be surgically sterile, postmenopausal or agree to use effective contraception during the period of therapy. Male patients must be surgically sterile or agree to use effective contraception during the period of therapy. Exclusion Criteria: * Squamous cell histology. * History of untreated brain metastases * Prior treatment with \>1 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV). * Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to bevacizumab, sunitinib, erlotinib, gefitinib, or thalidomide). * Prior chemotherapy, radiation therapy, surgery, or investigational agent within 4 weeks prior to study entry, except palliative radiation therapy to a non-target lesions (must have been completed 2 weeks prior to study enrollment). * Eligibility of patients receiving any medications or substances known to induce or inhibit CYP3A4 and /or with the potential to affect the activity or pharmacokinetics of sunitinib or erlotinib will be determined following review of their case by the Principal Investigator. * NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy. * Ongoing treatment with warfarin * Prior treatment with high-dose chemotherapy requiring stem cell rescue. * Prior irradiation to \>25% of the bone marrow (whole pelvis = 25%). * Diagnosis within prior 3 years of second malignancy, except basal cell carcinoma, squamous cell skin carcinoma or in situ carcinoma that has been completely treated without evidence of recurrent disease for 12 months. * Current treatment on another therapeutic clinical trial or receipt of another investigative agent within 4 weeks of study entry. * Any of the following within 12 months prior to starting study treatment: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus. * Hypertension (\>150/100mmHg) that cannot be controlled with standard antihypertensive agents. * Ongoing cardiac dysrhythmias of grade \>2, ≥ grade 3 atrial fibrillation, or QTc interval of \>450 msec for males and \>470 msec for females. * Evidence of hemoptysis \<4 weeks of starting study treatment. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality * HIV-positive patients * Women who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.