What Is Necitumumab?
Necitumumab is a medication studied in clinical trials primarily for various types of cancer. The specific mechanism by which Necitumumab works in the body is not detailed in the provided trial descriptions. It is administered intravenously (IV).
This drug has been investigated as a treatment for conditions such as metastatic non-small cell lung carcinoma, non-small cell lung cancer, and other malignant solid tumors. Sponsors involved in these studies include Eli Lilly and Company, along with other institutions like the National Cancer Institute (NCI) and AstraZeneca. The first clinical trial involving Necitumumab began on 2009-02-03, and the most recent one started on 2020-02-26. In total, 21 clinical trials have explored Necitumumab, with 13 of these studies already completed. These trials have collectively enrolled 3,043 participants.
Uses and Conditions Under Study
Necitumumab has been studied in clinical trials for several types of cancer, primarily focusing on lung cancers and other solid tumors.
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Non-Small Cell Lung Cancer (NSCLC): Necitumumab has been extensively investigated for various forms of NSCLC, including metastatic lung non-small cell carcinoma, non-small cell lung cancer, metastatic squamous non-small cell lung cancer, and non-small cell lung carcinoma. NSCLC is a common type of lung cancer, and treatments often aim to target specific pathways involved in cancer growth. Necitumumab has been evaluated in 10 trials across these related lung cancer conditions, often in combination with chemotherapy regimens like gemcitabine and cisplatin.
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Other Malignant Solid Tumors: Beyond lung cancer, Necitumumab has also been explored for its potential role in treating other advanced cancers. This includes studies for malignant solid tumors, neoplasm metastasis (the spread of cancer), and metastatic colorectal cancer. These trials aim to assess the safety and effectiveness of Necitumumab in a broader range of cancers where standard treatments may be limited. A total of 3 trials have focused on these broader categories of solid tumors and metastasis.
Dosing
Necitumumab is administered intravenously (IV). Clinical trials have investigated specific dosing schedules for this medication, often as part of a multi-drug regimen.
One common dosing schedule studied involves Necitumumab given at 800mg IV on Day 1 and Day 8 of a treatment cycle. This cycle is typically repeated every 21 days, for up to 3 cycles or as determined by the study protocol. Necitumumab has been studied both as a single agent and in combination with other anti-cancer therapies. Examples of combinations include:
- Necitumumab with gemcitabine and cisplatin
- Necitumumab with gemcitabine and carboplatin
- Necitumumab with paclitaxel and carboplatin
- Necitumumab with pemetrexed and cisplatin
- Necitumumab with osimertinib
- Necitumumab with pembrolizumab
- Necitumumab with abemaciclib
The specific dosage and administration schedule for Necitumumab can vary depending on the particular clinical trial and the combination therapies being investigated. No specific pediatric dosing information was provided in the trial data.
Side Effects
The provided clinical trial data for Necitumumab does not contain detailed information on specific adverse events (side effects) or their frequencies. Therefore, a comprehensive list of common side effects with comparative rates against placebo cannot be presented here.
In one study (NCT00835185) involving Necitumumab combined with mFOLFOX-6 for colorectal cancer, participants experienced adverse events, serious adverse events, or death. However, specific types of side effects and their individual rates were not detailed in the available outcomes.
Clinical Trial Results
Necitumumab has been studied in several clinical trials for various cancers.
Colorectal Cancer
- In a study (NCT00835185) of Necitumumab combined with mFOLFOX-6 for colorectal cancer, patients experienced a median overall survival of 22.5 months.
- The median time patients lived without their cancer progressing (progression-free survival) was 10.0 months.
- About 63.6% of participants achieved an objective response, meaning their tumors either completely disappeared or significantly shrank. The median duration of this response was 10.0 months.
Squamous Non-Small Cell Lung Cancer
- A study (NCT00981058) compared Necitumumab plus gemcitabine and cisplatin to gemcitabine and cisplatin alone in patients with stage IV squamous non-small cell lung cancer.
- Patients treated with Necitumumab in combination therapy had a median overall survival of 11.5 months, compared to 9.9 months for those receiving chemotherapy alone.
- The median progression-free survival was 5.7 months with Necitumumab combination therapy, versus 5.5 months with chemotherapy alone.
- The objective response rate (percentage of patients with complete or partial tumor shrinkage) was 31.2% for the Necitumumab combination, compared to 28.8% for chemotherapy alone.
- Median time to treatment failure was 4.3 months with Necitumumab combination therapy, versus 3.6 months with chemotherapy alone.
Nonsquamous Non-Small Cell Lung Cancer
- Another study (NCT00982111) investigated Necitumumab combined with pemetrexed and cisplatin for stage IV nonsquamous non-small cell lung cancer, against pemetrexed and cisplatin alone.
- In this population, the addition of Necitumumab did not show an improvement in overall survival, with both groups having a median overall survival of approximately 11.3 to 11.5 months.
- Median progression-free survival was also similar, at 5.6 months for both treatment groups.
- The objective response rate was 31.1% for the Necitumumab combination and 32.1% for chemotherapy alone.
Advanced Solid Tumors (Monotherapy)
- In a study (NCT01624467) evaluating Necitumumab
Currently Recruiting Trials
Currently, there are no clinical trials actively recruiting participants for studies involving Necitumumab. This means that at this time, opportunities to join a new study for this treatment are not available.
Where to Participate
As there are no currently recruiting trials for Necitumumab, there are no active study sites or locations seeking participants. When trials are active, they typically specify eligibility criteria for potential participants. For Necitumumab studies, participants have generally included individuals of all genders, and healthy volunteers and children are typically excluded from participation.
Development Timeline
The journey of Necitumumab in clinical research began on February 3, 2009, with its first recorded clinical trial. Over the years, its development has seen a total of 21 clinical trials, enrolling over 3,000 participants. The primary sponsor driving much of this research has been Eli Lilly and Company, leading 14 of these studies. Other institutions and companies, including Glycotope GmbH, ImmunityBio, Inc., and the National Cancer Institute (NCI), have also contributed to its development.
Initial investigations into Necitumumab explored conditions such as IBS-C and hyperphosphatemia. However, the focus of its development soon shifted and significantly expanded. Researchers began to explore its potential in various forms of cancer, particularly Non-small Cell Lung Cancer (NSCLC) and its metastatic forms. The pipeline broadened to include studies for Malignant Solid Tumor, Metastatic Colorectal Cancer, Squamous Cell Carcinoma, and specific stages of lung cancer like Stage IV Non-Small Cell Lung Cancer.
The drug's progression through clinical phases included 6 Phase 1 trials, 10 Phase 2 trials, 3 combined Phase 1/Phase 2 trials, and two Phase 3 trials, indicating a comprehensive evaluation of its safety and efficacy as it advanced towards potential therapeutic use.