Clinical trial · Interventional
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
NCT00416650CI-TRIAL-00009897completedPhase 2ClinicalTrials.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)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- description
- Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
- interventionNames
- Drug: erlotinib hydrochloride
Primary outcomes (1)
- measure
- Major objective response rate (complete response and partial response)
- timeFrame
- At 4 weeks and then every 8 weeks
- description
- Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions
Secondary outcomes (3)
- measure
- Worst grade toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC) * Stage IIIB (malignant pleural or pericardial effusion) disease * Stage IV disease * Recurrent and/or medically inoperable disease * Measurable or evaluable indicator lesions * No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids) PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% * Life expectancy ≥ 8 weeks * WBC ≥ 3,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.0 mg/dL * AST ≤ 2 times upper limit of normal * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No significant medical history or unstable medical condition, including any of the following: * Unstable systemic disease * Congestive heart failure * Recent myocardial infarction * Unstable angina * Active infection * Uncontrolled hypertension * No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior radiation therapy to a major bone marrow-containing area * At least 3 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen for NSCLC * No prior systemic cytotoxic chemotherapy for other malignant diseases * No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib) * No concurrent radiotherapy or chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.