Clinical trial · Interventional
Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection
Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer
- 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)
This phase II trial is studying how well erlotinib works in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib before surgery may shrink the tumor so that it can be removed.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic endoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib)
- description
- Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity. Patients then undergo surgical resection on the last day of study drug administration (day 14 or day 21). Patients may receive chemotherapy and/or radiotherapy after surgical resection at the discretion of the primary physician.
- interventionNames
- Drug: erlotinib hydrochloride
- Procedure: therapeutic endoscopic surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Biochemical response rate in tumor defined as > 75% decrease in P-MAPK and/or P-AKT
- timeFrame
- Up to 5 years
Secondary outcomes (1)
- measure
- Tolerability of erlotinib, graded according to the NCI CTCAE version 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with suspicion of lung cancer without distant metastases * Patients are scheduled to have a tissue diagnostic procedure within 3 to 5 days of pre-registration * Patients are willing to allow collection and submission of baseline and post-therapy tumor tissue, skin and blood samples for this study * Patients must have ECOG performance status of 0, 1, or 2 * Patients must have no psychological, familial, sociological, or geographic conditions that will interfere with medical follow-up and compliance with the study protocol * Patients must have no prior chemotherapy or radiation therapy or no prior anti- EGFR treatment exposure * Patients must be able to take oral medication and not have malabsorption syndrome, or prior gastrointestinal surgery that limits their absorption (i.e. requiring total parental nutrition) * Patients must not be using phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, oxcarbazepine, rifapentine, St John's Wort, or any other CYP 3A4 enzyme-inducing agent; any use of these substances must be discontinued at least 2 weeks prior to registration * Patients must not be taking any anti-coagulants * Patients must not have been treated with a non-approved or investigational drug within 21 days prior to pre-registration; patients must not have serious underlying medical condition that would impair the ability of patient to receive the planned treatment * Patients with a known hypersensitivity to OSI-774 (erlotinib) are not eligible * Patients must have histologically confirmed NSCLC; cytologic specimens obtained by brushing, washing or needle aspiration of defined lesions will be acceptable * Patients must have stage IA (T1N0M0), stage IB (T2N0M0), stage IIA (T1N1M0), stage IIB (T2N1M0; T3N0-1M0), or stage IIIA (T1-3N2M0) disease * Patients with small cell component on histology specimen are not eligible * A paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC and obtained during the diagnostic biopsy is available for submission * Patients must be considered operable candidates and disease must be considered resectable * Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk * All females of childbearing potential must have a blood test or urine study within 1 week, prior to registration to rule out pregnancy * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * WBC \>= 3500/mm\^3 * ANC \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin \< 1.5mg/dL * SGPT and SGOT \< 3 times institution's upper limit of normal * Serum creatinine \< 2mg/dl or creatinine clearance \>= 20 ml/min
References
Publications (0)
Data not yet available