Clinical trial · Interventional
Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic 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)
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Docetaxel (Taxane) | Drug | Docetaxel | ALIAS |
| Paclitaxel (Taxane) | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cetuximab+Taxane+Carboplatin (C/T/C)
- description
- Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
- interventionNames
- Drug: Paclitaxel (Taxane)
- Drug: Docetaxel (Taxane)
- Drug: Carboplatin
- Drug: Cetuximab
- type
- ACTIVE_COMPARATOR
- label
- Taxane+Carboplatin (T/C)
- description
- A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy. * Tumor/disease lesions that can be measured bidimensionally. * Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work). * Adequate recovery from recent surgery or radiation therapy. * Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest. * Accessible for treatment, follow-up and required visits at a participating center(s). Exclusion Criteria: * Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer. * Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy. * Prior severe infusion reaction to antibody therapy. * Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial). * Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol. * Serious uncontrolled medical disorders that would impair the ability to receive therapy. * History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure. * Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible. * Peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event \[CTCAE\] Version 3.0). * Inadequate hematologic and/or liver and/or kidney function. * Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study. * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment prior to study drug administration. * Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
References
Publications (0)
Data not yet available