- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01469000
A Study of Pemetrexed and Gefitinib Versus Gefitinib in Non-Small Cell Lung Cancer (NSCLC)
28 agosto 2019 aggiornato da: Eli Lilly and Company
A Randomised Phase 2 Trial of Pemetrexed and Gefitinib Versus Gefitinib as First Line Treatment for Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
The purpose of this study is to compare the combination of pemetrexed and gefitinib versus gefitinib alone, in terms of progression-free survival.
This study is in participants who have stage IV non squamous NSCLC with activating epidermal growth factor mutations and who have not had any previous chemotherapy for stage IV disease.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
195
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 100036
- 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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Changchun, Cina, 130012
- 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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Changsha, Cina, 410013
- 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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Guang Zhou, Cina, 510120
- 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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Sichuan, Cina, 610041
- 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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Cheong Ju-City, Corea, Repubblica di, 361-711
- 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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Incheon, Corea, Repubblica di, 405-760
- 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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Seoul, Corea, Repubblica di, 135 720
- 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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Suwon-City, Corea, Repubblica di, 442-723
- 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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Aichi, Giappone, 464-8681
- 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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Chiba, Giappone, 277 8577
- 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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Hyogo, Giappone, 650-0046
- 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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Kanagawa, Giappone, 228-0329
- 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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Okayama, Giappone, 710-8602
- 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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Osaka, Giappone, 589-8511
- 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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Shizuoka, Giappone, 411-8777
- 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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Tokyo, Giappone, 104-0045
- 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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Yamaguchi, Giappone, 755-0241
- 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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Jhonghe City, Taiwan, 235
- 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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Kaohsiung, Taiwan, 824
- 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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Keelung, Taiwan, 204
- 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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Kuei Shan Hsiang, Taiwan, 33305
- 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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Niao Sung Hsiang, Taiwan, 833
- 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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Taichung, Taiwan, 40705
- 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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Taipei, Taiwan, 100
- 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Histologically or cytologically confirmed advanced (Stage IV) or recurrent non-squamous NSCLC
- Eligible participants of reproductive potential must agree to use adequate contraceptive methods during the study period and for at least 6 months after the last dose of study therapy
- Negative pregnancy test for women of childbearing potential
- Males or females, aged 18 years or above
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- The participant's primary NSCLC tumor has an activating Epidermal Growth Factor Receptor (EGFR) mutation, as determined by any validated method
- The participant consents to provide a tissue sample for prestudy EGFR mutation testing and the tumor tissue sample is available for detection of EGFR expression and other markers for centralized testing by Lilly
- The participant has measurable disease at the time of study entry, documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- The participant has not had any prior systemic chemotherapy, immunotherapy, or biological therapy (for example, targeted therapy, such as erlotinib or gefitinib) for Stage IV or recurrent non-squamous NSCLC
The participant has adequate organ function, defined as:
- White blood cell count ≥3 x 10^9/liter (L); absolute neutrophil count (segmented and bands) ≥1.5 x 10^9/L; platelet count ≥100 x 10^9/L; hemoglobin ≥9.0 gram per deciliter (g/dL)
- Total bilirubin ≤1.5 times the upper limit of the normal (ULN) range; and alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times ULN (or ≤5 times ULN if the liver has tumor involvement)
- Calculated creatinine clearance ≥45 milliliter per minute (mL/min)
- The participant is able to take folic acid, vitamin B12, and dexamethasone, according to the protocol's requirements
- Life expectancy of at least 3 months
- Provision of informed consent
- Prior radiation therapy is allowed to <25% of the bone marrow; however, prior radiation to the whole pelvis not allowed. Prior radiation therapy must be completed at least 2 weeks prior to first study-drug administration. Participants must have recovered from the acute toxic effects prior to first study-drug administration.
Exclusion Criteria:
- The participant has received prior chemotherapy for advanced and/or metastatic disease, or adjuvant/neoadjuvant treatment with pemetrexed or an EGFR-tyrosine Kinase inhibitor (TKI)
- The participant's tumor contains predominantly small cell lung cancer or squamous NSCLC
- The participant is receiving concurrent treatment with any other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, biological or targeted therapy, or radiotherapy (palliative irradiation of bone lesions is allowed)
- The participant has untreated central nervous system (CNS) metastases Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radiosurgery) ending at least 2 weeks before enrollment, or after surgical resection performed at least 28 days before enrollment. No evidence of Grade ≥1 CNS hemorrhage based on pretreatment MRI or Intravenous (IV) contrast CT scan (performed within 21 days before randomization).
- The participant has undergone radiotherapy within 28 days before enrollment (localized radiotherapy for pain relief allowed, provided 25% or less of their total bone marrow had been irradiated)
- The participant has clinically relevant congestive heart failure (New York Heart Association [NYHA] II-IV) or symptomatic or poorly controlled cardiac arrhythmia
The participant has a serious illness or medical condition that would compromise their safety or impair their ability to comply with the protocol's requirements, including, but not limited to, the following:
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
- Active or uncontrolled clinically serious infection
- Previous or concurrent 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 5 years prior to the study
- Uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the participant ineligible for entry into this study
- The participant has significant third space fluid retention, and is not amenable for required repeated drainage
- Known allergy or hypersensitivity reaction to any of the treatment components
- Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
- Concomitant use of cytochrome P450 (CYP)3A4 inducers or CYP3A4 inhibitors
- Participants under therapy with warfarin or coumarin derivatives who are unable to switch to low molecular weight heparin, unless regular monitoring of changes in prothrombin time (PT) (PT/international normalized ratio [INR]) will be applicable
- Any known significant ophthalmologic abnormalities of the surface of the eye. The use of contact lenses is not recommended during the study
- 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, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Participants participating in surveys or observational studies are eligible to participate in this study
- The participant has previously received treatment with gefitinib, erlotinib or pemetrexed
- Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.
- Have preexisting idiopathic pulmonary fibrosis as evidenced by computed tomography (CT) scan/x-ray at baseline; have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on an x-ray; have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids.
- The participant is pregnant or breastfeeding
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 250 mg Gefitinib/500 mg Pemetrexed
250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib taken orally QD.
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250 mg orally once per day.
Number of cycles until disease progression or unacceptable toxicity develops.
Altri nomi:
500 mg/m² IV on day 1 of each 21 day cycle.
Number of cycles until disease progression or unacceptable toxicity develops.
Altri nomi:
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Comparatore attivo: 250 mg Gefitinib
250 milligrams (mg) Gefitinib taken orally QD
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250 mg orally once per day.
Number of cycles until disease progression or unacceptable toxicity develops.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression Free Survival (PFS)
Lasso di tempo: Randomization to Progressive Disease or Death Due to Any Cause (Up to 58.78 Months)
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PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause,whichever is earlier.The censoring is taken in the following order: If a participant didn't have a complete baseline disease assessment,then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death has been observed for the participant;otherwise,if a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis,the PFS time will be censored at the last complete objective progression-free disease assessment date.Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study.
Also,the sum must also demonstrate an absolute increase of at least 5 millimeter (mm).The appearance of one or more new lesions is also considered progression.
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Randomization to Progressive Disease or Death Due to Any Cause (Up to 58.78 Months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Time To Progressive Disease (TTPD)
Lasso di tempo: Randomization to Progressive Disease (Up To 58.78 Months)
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TTPD is defined as time from the date of randomization to the first date of disease progression.
For each participant who is not known to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, or who has died without progression of disease, TTPD will be censored for that analysis at the date of the participant's last tumor assessment prior to that cut-off date.
TTPD was analyzed twice: (1) excluding clinical progressions of disease (that is,those not defined according to the RECIST version 1.1 criteria ), and (2) including clinical progressions.
Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Also, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm).
The appearance of one or more new lesions is also considered progression.
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Randomization to Progressive Disease (Up To 58.78 Months)
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Overall Survival (OS)
Lasso di tempo: Randomization to Date of Death Due to Any Cause (Up To 67.12 Months)
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OS is defined as the time from randomization to the date of death from any cause.
Survival time is censored at the date of last contact for participants who are still alive or lost to follow up.
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Randomization to Date of Death Due to Any Cause (Up To 67.12 Months)
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Lasso di tempo: Randomization to Progressive Disease (Up to 57.36 Months)
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ORR 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).
Complete Response (CR) is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Tumor marker results must have normalized.
Partial Response (PR) is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
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Randomization to Progressive Disease (Up to 57.36 Months)
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Percentage of Participants With CR, PR, and Stable Disease (SD) (Disease Control Rate [DCR])
Lasso di tempo: Randomization to Progressive Disease (Up To 57.36 Months)
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Disease control rate is the percentage of participants with a confirmed CR, PR or SD as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria.
CR is defined as disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Tumor marker results must have normalized.
PR is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Randomization to Progressive Disease (Up To 57.36 Months)
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Duration of Response (DoR)
Lasso di tempo: First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 57.36 Months)
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DoR was defined as the time from the date of the first CR or PR to the first date of Progressive Disease (PD) ( RECIST 1.1 Criteria) or death from any cause.CR is the disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to <10 mm.Tumor marker results must have normalized.
PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Also,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Participants not known to have died or to have had progression of disease as of the data-inclusion cut-off date for a particular analysis,duration of tumor response was censored at the date of the participants last tumor assessment prior to that cut-off date.
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First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 57.36 Months)
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Time to Worsening of Symptom (TWS) as Per Lung Cancer Symptom Scale (LCSS)
Lasso di tempo: Baseline to Progressive Disease (Up To 50 Months )
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TWS was the elapsed time from the date of randomization to the first date of worsening in any one of the 6 LCSS symptoms.
The LCSS (patient and observer) were administered at baseline and at the end of each 21-day cycle, until disease progression, and at short-term follow-up.
Content for the patient version -collected using a visual analog scale (VAS) anchored at 0 and 100, respectively representing the best and worst outcome- included 6 disease-specific measures: (appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summary consequences of lung cancer (overall symptom burden, diminished normal activities, and lowered quality-of-life).The observer version included only the 6 disease-specific measures and the responses were collected using a 5-point ordinal scale that was reverse coded with 0 and 100 respectively representing the worst and best outcome.TWS was censored at the date of the last LCSS assessment for participants who were not known to have LCSS worsening.
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Baseline to Progressive Disease (Up To 50 Months )
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2012
Completamento primario (Effettivo)
1 aprile 2015
Completamento dello studio (Effettivo)
1 novembre 2017
Date di iscrizione allo studio
Primo inviato
8 novembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
8 novembre 2011
Primo Inserito (Stima)
10 novembre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 agosto 2019
Ultimo verificato
1 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori della sintesi degli acidi nucleici
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Antagonisti dell'acido folico
- Gefitinib
- Pemetrexed
Altri numeri di identificazione dello studio
- 14034
- H3E-CR-JMIT (Altro identificatore: Eli Lilly and Company)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Periodo di condivisione IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Carcinoma, polmone non a piccole cellule
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Taichung Veterans General HospitalCompletatoCardiotossicità | Carcinoma Polmonare Non a Piccole Cellule (MeSH Term: Carcinoma, Non-Small-Cell Lung) | Effetti Collaterali e Reazioni Avverse Correlati ai Farmaci (Termine MeSH) | Inibitore della Tirosin-chinasi dell'EgfrTaiwan
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Fondazione del Piemonte per l'OncologiaReclutamentoCancro al seno | Cancro ovarico | Cancro del colon-retto | Melanoma (cancro della pelle) | Carcinoma Polmonare Non a Piccole Cellule (MeSH Term: Carcinoma, Non-Small-Cell Lung)Italia
Prove cliniche su Gefitinib
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Sun Yat-sen UniversityRitirato
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Jiangsu Famous Medical Technology Co., Ltd.SconosciutoCarcinoma polmonare non a piccole cellule
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Qilu Pharmaceutical Co., Ltd.SconosciutoCarcinoma polmonare non a piccole celluleCina
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Kunming Medical UniversityTerminatoCarcinoma polmonare non a piccole celluleCina
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Anhui Medical UniversitySconosciutoAutoefficacia | Tossicità del farmacoCina
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Fuzhou General HospitalNon ancora reclutamentoCancro ai polmoni
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NCIC Clinical Trials GroupCompletatoCancro alla prostataCanada
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University of Maryland, BaltimoreNational Cancer Institute (NCI); University of Maryland Greenebaum Cancer CenterCompletatoCancro ai reniStati Uniti
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletatoCancro ovarico | Cancro primitivo della cavità peritonealeStati Uniti, Canada, Regno Unito, Australia
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AstraZenecaTerminatoCarcinoma polmonare non a piccole celluleItalia