Advanced Non-Small Cell Lung CancerPhase 3NCT00948675
Study of Participants With Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing Pemetrexed, Carboplatin and Paclitaxel in people with Advanced Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 45 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 45 sitesUnited States
- Study dates
- 1 Sep 2009to 6 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
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.
Albuquerque, New Mexico, 87106
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Ann Arbor, Michigan, 48106
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Athens, Georgia, 30607
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Augusta, Georgia, 30901
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Aventura, Florida, 33180
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Billings, Montana, 59107
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Bismarck, North Dakota, 58501
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Branson, Missouri, 65616
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Burlington, North Carolina, 27215
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Chattanooga, Tennessee, 37404
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Cincinnati, Ohio, 45242
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Columbia, South Carolina, 29210
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Daytona Beach, Florida, 32114
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DuBois, Pennsylvania, 15801
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Fargo, North Dakota, 58122
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Fort Myers, Florida, 33916
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Fort Worth, Texas, 76104
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Gainesville, Florida, 32610
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Goshen, Indiana, 46526
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Great Falls, Montana, 59405
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Gurnee, Illinois, 60031
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High Point, North Carolina, 27262
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Houston, Texas, 77030
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Jacksonville, Florida, 32256
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Joliet, Illinois, 60435
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Kennewick, Washington, 99336
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Lansing, Michigan, 48910
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Macon, Georgia, 31201
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38119
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Mission Hills, California, 91345
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Mount Sterling, Kentucky, 40353
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Nashville, Tennessee, 37203
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New Albany, Indiana, 47150
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Philadelphia, Pennsylvania, 19107
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Port Saint Lucie, Florida, 34952
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Post Falls, Idaho, 83854
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Richmond, Virginia, 23230
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Rochester, Minnesota, 55905
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Salt Lake City, Utah, 84106
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Scottsdale, Arizona, 85259
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Sioux City, Iowa, 51101
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Southfield, Michigan, 48075
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Tucson, Arizona, 85715
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Tulsa, Oklahoma, 74136
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed, Carboplatin, Paclitaxel, Bevacizumab
- Keywords
- Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology, Advanced Lung Cancer, Non-Small Cell Lung Cancer, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called ALIMTA, LY231514
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.
CarboplatinDrug
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.
PaclitaxelDrug
Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours
BevacizumabBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed + Carboplatin + Pemetrexed | Experimental | Pemetrexed and Carboplatin followed by Pemetrexed Receives: Drug: Pemetrexed; Drug: Carboplatin |
| Paclitaxel + Carboplatin + Bevacizumab | Active comparator | Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab Receives: Drug: Carboplatin; Drug: Paclitaxel; Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
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.
Measured: Randomization to measured progressive disease or treatment discontinuation up to 39.49 months
Secondary outcomes (4)
Progression Free Survival (PFS)
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.
Measured: Randomization to measured progressive disease up to 39.49 months
Overall Survival (OS)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline to date of objective progressive disease up to 39.49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study start1 Sep 2009
- Primary completion31 Jan 2013
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948675
- Sponsor's protocol ID
- 13258
- Other IDs
- H3E-US-S130
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2009
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25371077
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00948675
- Acronym / sponsor ID
- 13258
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Keywords
- Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology, Advanced Lung Cancer, Non-Small Cell Lung Cancer, Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Jan 2013 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed + Carboplatin + Pemetrexed | Experimental | Drug: Pemetrexed, Drug: CarboplatinPemetrexed and Carboplatin followed by Pemetrexed |
| Paclitaxel + Carboplatin + Bevacizumab | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Biological: BevacizumabPaclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: ALIMTA, LY231514Induction 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. | Drug | Pemetrexed + Carboplatin + Pemetrexed |
| CarboplatinInduction 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. | Drug | Paclitaxel + Carboplatin + Bevacizumab, Pemetrexed + Carboplatin + Pemetrexed |
| PaclitaxelInduction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours | Drug | Paclitaxel + Carboplatin + Bevacizumab |
| BevacizumabInduction 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. | Biological | Paclitaxel + Carboplatin + Bevacizumab |
Primary outcome
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: 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.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: Randomization to measured progressive disease up to 39.49 months
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to date of objective progressive disease up to 39.49 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25371077Zinner 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pemetrexed, Carboplatin and Paclitaxel in people with Advanced Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (time frame: Randomization to measured progressive disease or treatment discontinuation up to 39.49 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.