Clinical trial · Interventional
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
- 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. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| Matched placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Tarceva (OSI-774, erlotinib) PO 150mg daily
- interventionNames
- Drug: erlotinib hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Matched placebo
- description
- Matched placebo PO daily
- interventionNames
- Drug: Matched placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- between date of randomisation and date of death from any cause
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Advanced disease (stage IIIB or IV) * Diagnosis within 62 days prior to randomization * Not suitable for first-line chemotherapy, as defined by the following criteria\*: * ECOG performance status 2-3 * ECOG performance status 0-1 AND creatinine clearance \< 60 mL/min * NOTE: \*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis * No symptomatic brain metastases PATIENT CHARACTERISTICS: * Estimated life expectancy of at least 8 weeks * Able to take oral medication * Not pregnant or nursing * Fertile patients must use effective contraception * No severe uncontrolled infection * No unstable angina * No myocardial infarction within the past month * No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) * No acute renal failure * Bilirubin \< 2 times upper limit of normal (ULN) * Transaminases \< 2 times ULN (5 times ULN if liver metastases are present) * Creatinine \< 5 times ULN * No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications * No other prior or current malignant disease likely to interfere with study treatment or comparisons PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab) * No prior palliative radiotherapy * Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks * No concurrent cyclooxygenase-2 inhibitors
References
Publications (0)
Data not yet available