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Study of Participants With Advanced Non-Small Cell Lung Cancer

18 oktober 2021 bijgewerkt door: Eli Lilly and Company

A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology

The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Geavanceerde niet-kleincellige longkanker

Interventie / Behandeling

Gedetailleerde beschrijving

This is a multicenter, randomized, open-label, Phase III trial. Eligible participants will be randomized in a 1:1 ratio to receive pemetrexed and carboplatin followed by pemetrexed or paclitaxel, carboplatin, and bevacizumab followed by bevacizumab as their study treatment. Participants randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, participants randomized to Paclitaxel + Carboplatin + Bevacizumab will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended in the paclitaxel label.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

361

Fase

Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Arizona
  - Scottsdale, Arizona, Verenigde Staten, 85259
    - 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.
  - Tucson, Arizona, Verenigde Staten, 85715
    - 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.
- California
  - Mission Hills, California, Verenigde Staten, 91345
    - 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.
- Florida
  - Aventura, Florida, Verenigde Staten, 33180
    - 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.
  - Daytona Beach, Florida, Verenigde Staten, 32114
    - 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.
  - Fort Myers, Florida, Verenigde Staten, 33916
    - 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.
  - Gainesville, Florida, Verenigde Staten, 32610
    - 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.
  - Jacksonville, Florida, Verenigde Staten, 32256
    - 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.
  - Port Saint Lucie, Florida, Verenigde Staten, 34952
    - 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.
- Georgia
  - Athens, Georgia, Verenigde Staten, 30607
    - 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.
  - Augusta, Georgia, Verenigde Staten, 30901
    - 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.
  - Macon, Georgia, Verenigde Staten, 31201
    - 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.
  - Marietta, Georgia, Verenigde Staten, 30060
    - 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.
- Idaho
  - Post Falls, Idaho, Verenigde Staten, 83854
    - 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.
- Illinois
  - Gurnee, Illinois, Verenigde Staten, 60031
    - 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.
  - Joliet, Illinois, Verenigde Staten, 60435
    - 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.
- Indiana
  - Goshen, Indiana, Verenigde Staten, 46526
    - 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.
  - New Albany, Indiana, Verenigde Staten, 47150
    - 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.
- Iowa
  - Sioux City, Iowa, Verenigde Staten, 51101
    - 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.
- Kentucky
  - Mount Sterling, Kentucky, Verenigde Staten, 40353
    - 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.
- Michigan
  - Ann Arbor, Michigan, Verenigde Staten, 48106
    - 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.
  - Lansing, Michigan, Verenigde Staten, 48910
    - 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.
  - Southfield, Michigan, Verenigde Staten, 48075
    - 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.
- Minnesota
  - Rochester, Minnesota, Verenigde Staten, 55905
    - 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.
- Missouri
  - Branson, Missouri, Verenigde Staten, 65616
    - 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.
- Montana
  - Billings, Montana, Verenigde Staten, 59107
    - 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.
  - Great Falls, Montana, Verenigde Staten, 59405
    - 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.
- New Mexico
  - Albuquerque, New Mexico, Verenigde Staten, 87106
    - 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.
- North Carolina
  - Burlington, North Carolina, Verenigde Staten, 27215
    - 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.
  - High Point, North Carolina, Verenigde Staten, 27262
    - 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.
- North Dakota
  - Bismarck, North Dakota, Verenigde Staten, 58501
    - 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.
  - Fargo, North Dakota, Verenigde Staten, 58122
    - 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.
- Ohio
  - Cincinnati, Ohio, Verenigde Staten, 45242
    - 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.
- Oklahoma
  - Tulsa, Oklahoma, Verenigde Staten, 74136
    - 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.
- Pennsylvania
  - DuBois, Pennsylvania, Verenigde Staten, 15801
    - 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.
  - Philadelphia, Pennsylvania, Verenigde Staten, 19107
    - 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.
- South Carolina
  - Columbia, South Carolina, Verenigde Staten, 29210
    - 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.
- Tennessee
  - Chattanooga, Tennessee, Verenigde Staten, 37404
    - 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.
  - Memphis, Tennessee, Verenigde Staten, 38119
    - 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.
  - Nashville, Tennessee, Verenigde Staten, 37203
    - 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.
- Texas
  - Fort Worth, Texas, Verenigde Staten, 76104
    - 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.
  - Houston, Texas, Verenigde Staten, 77030
    - 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.
- Utah
  - Salt Lake City, Utah, Verenigde Staten, 84106
    - 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.
- Virginia
  - Richmond, Virginia, Verenigde Staten, 23230
    - 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.
- Washington
  - Kennewick, Washington, Verenigde Staten, 99336
    - 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.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

a histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC) [Stage IV from the American Joint Committee on Cancer Staging Criteria (AJCC) staging system, version 7.0, including both M1a and M1b], other than predominantly squamous cell histology, that is not amenable to curative therapy. Participants may not have received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy, including adjuvant therapy, for any stage of NSCLC.
prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis not allowed.
good performance status.
adequate organ function.
estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

known central nervous system (CNS) disease, other than treated brain metastasis.
major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to study or have an anticipated need for major surgery during the study.
core biopsy or other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 7 days prior to study.
history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
currently receiving ongoing treatment with full-dose warfarin or equivalent
significant vascular disease within 6 months prior to Day 1 of Cycle 1.
evidence of bleeding diathesis or coagulopathy.
serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
serious cardiac condition, such as myocardial infarction, angina, or heart disease.
inadequately controlled hypertension.
any prior history of hypertensive crisis or hypertensive encephalopathy.
serious, nonhealing wound, active ulcer, or untreated bone fracture.
another active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab (prior intravitreal administration of bevacizumab does not preclude study participation).
pregnant or breast-feeding.
history of stroke or transient ischemic attack within 6 months prior to study.
known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
history of hemoptysis within 3 months prior to randomization.
unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
unwilling to take folic acid or vitamin B12 supplementation.
clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage. Participants with M1a disease with pleural effusions are eligible if the effusions can be adequately controlled.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Pemetrexed + Carboplatin + Pemetrexed Pemetrexed and Carboplatin followed by Pemetrexed	Geneesmiddel: Pemetrexed Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation. Andere namen: ALIMTA, LY231514 Geneesmiddel: Carboplatin Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.
Actieve vergelijker: Paclitaxel + Carboplatin + Bevacizumab Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab	Geneesmiddel: Carboplatin Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes. Geneesmiddel: Paclitaxel Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours Biologisch: Bevacizumab Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: Pemetrexed + Carboplatin + Pemetrexed

Pemetrexed and Carboplatin followed by Pemetrexed

Geneesmiddel: Pemetrexed

Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.

Andere namen:

ALIMTA, LY231514

Geneesmiddel: Carboplatin

Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.

Actieve vergelijker: Paclitaxel + Carboplatin + Bevacizumab

Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab

Geneesmiddel: Carboplatin

Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.

Geneesmiddel: Paclitaxel

Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours

Biologisch: Bevacizumab

Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Tijdsspanne: Randomization to measured progressive disease or treatment discontinuation up to 39.49 months	G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.	Randomization to measured progressive disease or treatment discontinuation up to 39.49 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Progression Free Survival (PFS) Tijdsspanne: Randomization to measured progressive disease up to 39.49 months	PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD was ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.	Randomization to measured progressive disease up to 39.49 months
Overall Survival (OS) Tijdsspanne: Randomization to date of death from any cause up to 39.49 months	OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.	Randomization to date of death from any cause up to 39.49 months
Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate) Tijdsspanne: Baseline to date of objective progressive disease up to 39.49 months	Overall Response rate (ORR) was the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.	Baseline to date of objective progressive disease up to 39.49 months
Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Tijdsspanne: Baseline to date of objective progressive disease up to 39.49 months	Disease control rate was 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) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate was calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.	Baseline to date of objective progressive disease up to 39.49 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Zinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2009

Primaire voltooiing (Werkelijk)

31 januari 2013

Studie voltooiing (Werkelijk)

6 november 2020

Studieregistratiedata

Eerst ingediend

28 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2009

Eerst geplaatst (Schatting)

29 juli 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

18 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

13258
H3E-US-S130 (Andere identificatie: Eli Lilly and Company)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD delen Ondersteunend informatietype

LEERPROTOCOOL
SAP
MVO

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Klinische onderzoeken op Geavanceerde niet-kleincellige longkanker

Taichung Veterans General Hospital

Voltooid

Cardiovasculaire disfunctie gerelateerd aan kankertherapie geassocieerd met EGFR-TKIs bij gevorderd EGFR-gemuteerd niet-kleincellig longcarcinoom

Cardiotoxiciteit | Niet-kleincellig longcarcinoom (MeSH Term: Carcinoma, Non-Small-Cell Lung) | Geneesmiddelgerelateerde bijwerkingen en ongewenste reacties (MeSH-term) | Egfr Tyrosinekinaseremmer

Taiwan
Royal Marsden NHS Foundation Trust
University of Cambridge; Royal Brompton & Harefield NHS Foundation Trust; Institute... en andere medewerkers

Werving

Haalbaarheidsstudie van weefsel- en bloedverzameling bij oncogene verslaafde en neoadjuvant behandelde niet-kleine cellongkanker (FeStival)

Niet-kleincellige longkanker | Gemetastaseerde niet-kleincellige longkanker | Lokaal geavanceerde NSCLC - niet-kleincellige longkanker | Oncogene verslaafde niet-kleine cellongkanker | Vroege operabele niet-kleine cellongkanker | Fase 2/3 Operable Non Small Cell Long Cancer

Verenigd Koninkrijk
Fondazione del Piemonte per l'Oncologia

Werving

Een studie naar biologische, genetische en constitutionele factoren en niet-invasieve monitoring om persoonlijke kankerrisico's te beoordelen (PRO-ACTIVE)

Borstkanker | Eierstokkanker | Colo-rectale kanker | Melanoom (huidkanker) | Niet-kleincellig longcarcinoom (MeSH Term: Carcinoma, Non-Small-Cell Lung)

Italië
Novartis Pharmaceuticals

Beëindigd

Dosisbepalingsonderzoek van TNO155 bij volwassen patiënten met vergevorderde solide tumoren

Melanoma | Geavanceerde EGFR -mutant Non Small Cell Lungcancer (NSCLC) | KRAS G12-MUTANT NSCLC | Slokdarm plaveiselcelkanker (SCC) | Hoofd/nek SCC | Geavanceerde gastro -intestinale stromale tumoren (GIST) | Geavanceerde NRAS/Braft WT Cutane melanoom

Verenigde Staten, Taiwan, Nederland, Canada, Spanje, Singapore, Italië, Japan, Zuid -Korea

Klinische onderzoeken op Pemetrexed

Boehringer Ingelheim

Beëindigd

BIBF 1120 in combinatie met pemetrexed bij gevorderde niet-kleincellige longkanker (NSCLC)

Carcinoom, niet-kleincellige long

Japan
Hunan Province Tumor Hospital
Hunan Cancer Hospital

Werving

Werkzaamheid en resistentiemechanismen van IP bij NSCLC met leptomeningeale metastasen (EPIC)

Niet-kleincellige longkanker

China
Shanghai Shengdi Pharmaceutical Co., Ltd

Nog niet aan het werven

Een fase II/III-onderzoek naar adebrelimab in combinatie met SHR-8068 en chemotherapie bij patiënten met gevorderd of gemetastaseerd NSCLC

Niet-plaveiselcel niet-kleincellige longkanker

China
Northwestern University
National Cancer Institute (NCI)

Onbekend

Pemetrexed-dinatrium bij de behandeling van patiënten met recidiverende maligne gliomen, primair CZS-lymfoom of hersenmetastasen

Lymfoom | Hersenen en tumoren van het centrale zenuwstelsel | Uitgezaaide kanker

Verenigde Staten
Pfizer

Beëindigd

Proef van Pemetrexed met of zonder PF-3512676 bij gevorderde niet-kleincellige longkanker

Carcinoom, niet-kleincellige long

Verenigde Staten, Duitsland, Italië
Rongjie Tao
National Natural Science Foundation of China

Onbekend

Hooggedoseerde Pemetrexed voor de behandeling van longadenocarcinoom met hersenmetastasen

Hersenmetastasen

China
Norwegian University of Science and Technology
St. Olavs Hospital

Beëindigd

Pemetrexed bij gevorderde niet-kleincellige longkanker: progressie versus onderhoudstherapie na inductiechemotherapie (IDA)

Carcinoom, niet-kleincellige long

Noorwegen
Ain Shams University

Onbekend

Vier versus zes cycli van Pemetrexed/Platinum voor MPM

Kwaadaardig pleuraal mesothelioom

Egypte
Eli Lilly and Company

Voltooid

Een studie van thuistoediening van pemetrexed als onderhoudsbehandeling voor geavanceerde niet-plaveiselcel niet-kleincellige longkanker (NSCLC)

Niet-kleincellige longkanker uitgezaaid | Niet-plaveiselcel niet-kleincellig neoplasma van de long | Niet-kleincellige longkanker stadium IIIB

Verenigd Koninkrijk, Zweden
The First Affiliated Hospital with Nanjing Medical...

Onbekend

Combinatiechemotherapie met of zonder anlotinib bij de onderhoudsbehandeling van niet-plaveiselcel niet-kleincellige longkanker.

Niet-plaveiselcel Niet-kleincellige longkanker

Study of Participants With Advanced Non-Small Cell Lung Cancer

A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Werkelijk)

Fase

Contacten en locaties

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Secundaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Tijdsspanne

Medewerkers en onderzoekers

Sponsor

Publicaties en nuttige links

Algemene publicaties

Studie record data

Bestudeer belangrijke data

Studie start (Werkelijk)

Primaire voltooiing (Werkelijk)

Studie voltooiing (Werkelijk)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Schatting)

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Beschrijving IPD-plan

IPD-tijdsbestek voor delen

IPD-toegangscriteria voor delen

IPD delen Ondersteunend informatietype

Klinische onderzoeken op Geavanceerde niet-kleincellige longkanker

Klinische onderzoeken op Pemetrexed

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Malawi

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties