A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Lilly

Status and phase: Withdrawn; Phase 2

Conditions: Locally Advanced Squamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Necitumumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02941601

16535

2016-002041-31 (EudraCT Number)

I4X-MC-JFDA (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Experimental group

Description:

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

Drug: Necitumumab

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Experimental group

Description:

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Treatment:

Drug: Gemcitabine

Drug: Carboplatin

Drug: Necitumumab