Clinical trial · Interventional
A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This was a strategic decision for business planning purposes and not out of concern for patient safety.
Summary
Brief summary (as posted)
The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Squamous Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Metastatic Squamous Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Necitumumab | Drug | Necitumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Necitumumab + Gemcitabine and Carboplatin
- description
- Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
- interventionNames
- Drug: Necitumumab
- Drug: Gemcitabine
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Cohort 2: Necitumumab + Gemcitabine and Carboplatin
- description
- Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
- interventionNames
- Drug: Necitumumab
- Drug: Gemcitabine
- Drug: Carboplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report. * Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2. * Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) * The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 * Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks) * The participant has archived tumor tissue available for biomarker analyses. * Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC. Exclusion Criteria: * The participant has nonsquamous NSCLC * The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor. * The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy). * The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. * The participant has a bleeding tumor. * The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment. * The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association. * The participant has experienced myocardial infarction within 6 months prior to study enrollment.
References
Publications (0)
Data not yet available