Clinical trial · Interventional
First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer
A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 1. Very low enrollment rate. 2. Recent studies question the effect of adding panitumumab in this category of patients. 3. Too high toxicity rate
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| panitumumab | Drug | Panitumumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 3 years
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
- Up to 3 years
- measure
- Overall survival
- timeFrame
- Up to 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic (stage IV) NSCLC * Measurable disease according to RECIST v.1.0 2009 * KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue. * Age ≥18 * PS \< 2 * Adequate organ function Haematology: * Neutrophil count ≥1.5x10\^9/L * Platelet count ≥100x10\^9/L * Leucocyte count \> 3,000/mm Hepatic function: * Total bilirubin ≤ 1.5 times the upper normal limit (UNL) * Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases Renal Function: * Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL Metabolic function: * Magnesium ≥ lower limit of normal. * Calcium ≥ lower limit of normal. Consent to translational research studies Written informed consent Exclusion Criteria: * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease. * Known CNS metastasis (pretreatment routine assessment not required) * Prior chemotherapy for metastatic disease * Indication for radiation therapy or prior radiotherapy within 30 days before treatment start. * Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ. * Other experimental therapy within 30 days prior to treatment initiation. * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. * Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. * Patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
References
Publications (0)
Data not yet available