Clinical trial · Interventional
A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer
A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT01788566CI-TRIAL-00022742completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.
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 |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Necitumumab | Drug | Necitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Cisplatin + Necitumumab
- description
- Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
- interventionNames
- Drug: Necitumumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)
- timeFrame
- Baseline to Measured Progressive Disease (up to 17 Months)
- description
- ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC) * Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition * Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 * Required to have a performance status (PS) 0-1 Exclusion Criteria: * Nonsquamous NSCLC * Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor * Previous chemotherapy for NSCLC * Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment * Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) * Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
References
Publications (0)
Data not yet available
No reference posted for this study.