Skip to main content
OpenTrials
Completed

NCT Number: NCT01897480

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herlev and Gentofte Hospital, Herlev, Capital Region, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
  • Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
  • Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
  • Availability of adequate tumor material (block or slides)

Exclusion criteria

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
  • Have previously completed or withdrawn from this study or any other study investigating LY2875358
  • Have a serious concomitant systemic disorder or significant cardiac disease
  • Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
  • Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
  • Have major surgery less than 2 weeks prior to the initiation of study treatment therapy
  • Pregnant or lactating women

Treatment and study plan

LY2875358

Biological

Administered IV

Erlotinib

Drug

Administered Orally

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)

Secondary outcomes

  1. Change in Tumor Size (CTS)

    Time frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)

  2. Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

    Time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)

  3. Duration of Response (DoR)

    Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)

  4. Time to Progressive Disease (TTPD)

    Time frame: Randomization to Objective Disease Progression (Estimated 3 Years)

  5. Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])

    Time frame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)

  6. Overall Survival (OS)

    Time frame: Randomization to Death Due to Any Cause (Estimated 5 Years)

  7. Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) C30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13)

    Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)

  8. Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib

    Time frame: Baseline through Cycle 4 (28 Day Cycle)

  9. Proportion of Participants with Anti-LY2875358 Antibody Response

    Time frame: Baseline through 30 Day Follow Up (Estimated 3 Years)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2026
First posted
Jul 12, 2013
Registry last updated
Jan 26, 2026

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.

Published trials that share one or more normalized conditions with this study.