LY2875358
BiologicalAdministered IV
NCT Number: NCT01897480
The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Herlev and Gentofte Hospital, Herlev, Capital Region, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered IV
Administered Orally
Time frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Time frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
Time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Time frame: Randomization to Objective Disease Progression (Estimated 3 Years)
Time frame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)
Time frame: Randomization to Death Due to Any Cause (Estimated 5 Years)
Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)
Time frame: Baseline through Cycle 4 (28 Day Cycle)
Time frame: Baseline through 30 Day Follow Up (Estimated 3 Years)
Eli Lilly and Company
Industry
A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib
Acronym: Balise
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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