Clinical trial · Interventional
A Study of Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
NCT00988858CI-TRIAL-00040655completedPhase 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 primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY2603618 | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LY2603618 and Pemetrexed
- interventionNames
- Drug: LY2603618
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
- timeFrame
- Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
- description
- Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must agree to have a tumor biopsy at screening * Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment * Must be available for the duration of the study and willing to follow the study procedures * If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug * Must have discontinued radiation therapy at least 4 weeks before entering this study Exclusion Criteria: * Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment. * Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the participant's physician considers it safe to become pregnant or father a child. * Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb). * Must not have previously participated in a study involving LY2603618 * Must not have previously taken pemetrexed for cancer * Must not have a known allergy to LY2603618 or pemetrexed * Must not currently have an infection that may affect participant's ability to tolerate the therapy * Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease * If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
References
Publications (1)
- DERIVEDScagliotti G, Kang JH, Smith D, Rosenberg R, Park K, Kim SW, Su WC, Boyd TE, Richards DA, Novello S, Hynes SM, Myrand SP, Lin J, Smyth EN, Wijayawardana S, Lin AB, Pinder-Schenck M. Phase II evaluation of LY2603618, a first-generation CHK1 inhibitor, in combination with pemetrexed in patients with advanced or metastatic non-small cell lung cancer. Invest New Drugs. 2016 Oct;34(5):625-35. doi: 10.1007/s10637-016-0368-1. Epub 2016 Jun 27. PMID 27350064