Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo
9 octobre 2020 mis à jour par: Eli Lilly and Company
Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer
This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:
- Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
- Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
35
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Gauting, Allemagne, 82131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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GroBhansdorf, Allemagne, D-22927
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg, Allemagne, D 21075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heidelberg, Allemagne, 69126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven, Belgique, 3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bergamo, Italie, 24128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Catania, Italie, 95100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Padova, Italie, 35128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Trento, Italie, 38100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Otwock, Pologne, 05-400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poznan, Pologne, 60-569
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest, Roumanie, 022328
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
- no prior systemic therapies [chemotherapy, et cetera (etc.)] or pleurodesis with chemotherapy for this disease
- prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and participant must be recovered from the acute toxic effects
- have a good performance status
- participant must sign an informed consent document
Exclusion Criteria:
- participant had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
- participant is unable to swallow tablets
- participant is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
- participant is unable to interrupt aspirin and/or other anti-inflammatory agents
- participant is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Enzastaurin + Pemetrexed + Cisplatin
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1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression
Autres noms:
500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
Autres noms:
75 mg/m², IV, every 21 days, for each 21-day cycle
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Comparateur placebo: Placebo + Pemetrexed + Cisplatin
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500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle
Autres noms:
75 mg/m², IV, every 21 days, for each 21-day cycle
po, QD
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation]
Délai: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up
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Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants.
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up
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Part 2: Compare Progression-Free Survival (PFS) Between the 2 Treatment Arms Through the Assessment of Tumor Response
Délai: Baseline to measured PD up to 5 months
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PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause.
For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment.
For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy.
PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured PD up to 5 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments
Délai: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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The safety and toxicity profile for Part 2 was defined as serious adverse events (SAEs) and other non-serious adverse events (AEs).
A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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Part 2: Number of Participants With a Complete Response (CR) or Partial Response (PR) (Response Rate)
Délai: Baseline to measured progressive disease (PD) up to 5 months
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Response rate was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria.
Complete Response (CR) was defined as the disappearance of all target lesions.
Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions.
Best response was confirmed by a second assessment in ≥28 days.
Response rate was defined as the number of participants with best response of CR or PR divided by the total number of treated participants.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured progressive disease (PD) up to 5 months
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Part 2: Overall Survival (OS)
Délai: Baseline to date of death from any cause up to 5 months
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OS time was defined as the time from the date of study enrollment to the date of death from any cause.
For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status).
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to date of death from any cause up to 5 months
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Part 2: Duration of Disease Control (DDC) and Response
Délai: Baseline to measured PD up to 5 months
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DDC and response defined as time from complete response (CR), partial response (PR) or stable disease (SD) to first date of objectively determined progressive disease (PD) or death from any cause using RECIST (v1.0) criteria.
CR defined as disappearance of all target lesions.
PR defined as having ≥30% decrease in sum of longest diameter (LD) of target lesions.
PD defined as having ≥20% increase in the sum of the LD of target lesions.
SD defined as small changes not meeting above criteria.
Participants not known to have died as of data cut-off date, had no objective PD or were lost to follow-up, DCC was censored at date of last objective progression-free assessment (OPFA).
Participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objective PD or death were censored at date of last OPFA prior to initiation of post discontinuation anticancer therapy.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline to measured PD up to 5 months
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Part 2: Time to Worsening of Symptoms (TWS)
Délai: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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TWS was measured from the date of study enrollment to the first date of a worsening in any of the 6 Lung Cancer Symptom Scale (LCSS) symptoms (appetite, cough, fatigue, shortness of breath, hemoptysis and pain).
Participants marked each symptom on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (as good as it can be/none) to 100 mm (as bad/much as it could be).
TWS was also measured individually for each of the 6 symptoms independently and were also measured from the date of enrollment to the first date of worsening in pain.
For both measurements, worsening was defined as a 15-mm increase from baseline in the participant-reported score for any symptom.
Participants who are not known to have had a worsening TWS were censored at the date of the participant's last LCSS assessment.
Zero participants were analyzed in this outcome as study was terminated early.
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Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up
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Part 2: To Assess Biomarkers of the Disease State and Their Correlation to Clinical Outcome
Délai: Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months
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Presented are data that evaluates of biomarkers relevant to the study drug and the disease state of the participant's clinical outcome.
Zero participants were analyzed in this outcome as study was terminated early.
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Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UCT/GMT - 5 hours, EST), Eli Lilly and Company
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2007
Achèvement primaire (Réel)
1 novembre 2008
Achèvement de l'étude (Réel)
1 novembre 2008
Dates d'inscription aux études
Première soumission
1 octobre 2007
Première soumission répondant aux critères de contrôle qualité
1 octobre 2007
Première publication (Estimation)
3 octobre 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de la synthèse des acides nucléiques
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Antagonistes de l'acide folique
- Pémétrexed
Autres numéros d'identification d'étude
- 10722
- H6Q-MC-S021 (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .