Clinical trial · Interventional
Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung
NCT00391586CI-TRIAL-00018846terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution.
Summary
Brief summary (as posted)
This study was conducted to compare the activities of erlotinib to that of intravenous, platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy, compared to historical controls.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| Platinum-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib followed by chemotherapy
- description
- Erlotinib: 150 mg orally once daily, Platinum-based chemotherapy regimen selections include: Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following: 1. Docetaxel 75 mg/m2, D1 2. Docetaxel 35 mg/m2, D1,8,15 3. Paclitaxel 200-225 mg/m2, D1 4. Paclitaxel 80-100 mg/m2, D1,8,15 Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following: 1. Etoposide 100 mg/m2 D1-3 2. Etoposide 200 mg/m2 orally D1-3 3. Pemetrexed 500 mg/m2, D 1 4. Irinotecan 50 mg/m2 D1,8,15 Other regimens: 1. Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8 2. Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1
- interventionNames
- Drug: Erlotinib
- Drug: Platinum-based chemotherapy
Primary outcomes (2)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 5 years
- measure
- Toxicity Profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Prior chemotherapy will be allowed for other invasive malignancies, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol. No prior chemotherapy for metastatic non-small cell lung cancer (NSCLC) will be allowed. Prior adjuvant or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months have elapsed from the last dose of chemotherapy to the documentation of relapsed disease. Baseline laboratory values (bone marrow, renal, hepatic): * Adequate bone marrow function: * Absolute neutrophil count \>1000/µL * Platelet count \>100'000/µL * Renal function: * Serum creatinine \< 2.0 mg % * Hepatic function: * Bilirubin \<1.5x normal * Serum calcium \< 12 mg/dl Other Eligibility Criteria: * Signed Informed Consent * Eastern Cooperative Oncology Group (ECOG)/Zubrod/Southwest Oncology Group (SWOG) Performance Status \<2 (Karnofsky Performance Status \> 70%) * Life expectancy \> 8 weeks * Male or female' age \>18 years * Patients of childbearing potential must be using an effective means of contraception. * Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease Exclusion Criteria: * Prior therapy with an epidermal growth factor receptor inhibitor, including erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting agent * Pregnant or lactating females * Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0 * Uncontrolled' clinically significant dysrhythmia * History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix * Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion * Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol) * Radiotherapy within the 2 weeks before Cycle 1' Day 1 * Surgery within the 2 weeks before Cycle 1' Day 1 * Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
References
Publications (0)
Data not yet available
No reference posted for this study.