A Phase 3 interventional study of Vandetanib and Pemetrexed in Non Small Cell Lung Cancer and Lung Cancer, sponsored by Genzyme, a Sanofi Company. Completed at 110 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Genzyme, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Treatment
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.
This randomized phase III non-small cell lung cancer clinical trial is studying the effect of Alimta (pemetrexed) plus vandetanib to see how well the combination works compared to Alimta (pemetrexed) alone in patients who have previously been treated for non-small cell lung cancer (NSCLC).
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 698 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Genzyme, a Sanofi Company is the lead sponsor of 308 studies on the registry; 5 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 19 (76%) have results posted.
First submitted before Genzyme became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo Vandetanib + Pemetrexed
Drug: Pemetrexed
Vandetanib + Pemetrexed
Drug: Vandetanib · Drug: Pemetrexed
oral once daily tablet
Also known as: ZACTIMA™, ZD6474, SAR390530
intravenous infusion
Also known as: Pemetrexed disodium, Alimta®
Progression-Free Survival (PFS) in the Overall Population
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Progression-Free Survival in the Female Population
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Overall Survival (OS)
The OS is defined as the time from date of randomization until death. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (i.e, their status must be known at the censored date and should not be lost to follow up or unknown).
Time frame: Time to death in months
Objective Response Rate (ORR)
The ORR is the number of participants that are responders i.e, those participants with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 6 weeks, progressive disease (PD) or NE.
Time frame: Each participant was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Disease Control Rate (DCR)
The DCR is defined as the number of patients who achieved disease control at 6 weeks following randomization. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 6 weeks.
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Duration of Response (DoR)
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment).
Time frame: RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomization until objective progression
Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score
TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.
Time frame: LCSS questionnaires are to be administered every 3 weeks after randomization
Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The ASBI is derived from 6 of LCSS's 9 items.
Time frame: ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomization
Longitudinal Analysis of Lung Cancer Symptom Scale Total Score
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all 9 visual analogue participant scales from "none" \[0 millimeter (mm)\] to "as much as it could be" (100 mm).
Time frame: LCSS questionnaires are to be administered every 3 weeks after randomization
Longitudinal Analysis of Average Symptom Burden Index Score
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the 6 symptom visual analogue patient scales from "none" (0 mm) to "as much as it could be" (100 mm).
Time frame: ASBI is a score taken from the LCSS questionnaires administered every 3 weeks after randomization
First participant enrolled 09 January 2007, last participant enrolled 29 February 2008, cut off date 05 September 2008.
| Milestone | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Started | 256 | 278 |
| Treated | 260 | 273 |
| Completed | 30 | 23 |
| Not completed | 226 | 255 |
| Withdrew: Discontinue treatment survival follow-up | 90 | 91 |
| Withdrew: Death | 122 | 147 |
| Withdrew: Withdrawal by subject | 9 | 10 |
| Withdrew: Lost to follow-up | 4 | 6 |
| Withdrew: Withdrawn due to other reason | 1 | 0 |
| Withdrew: Randomised but no treatment received | 0 | 1 |
| Milestone | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Started | 120 | 114 |
| Treated with vandetanib | 124 | 110 |
| Completed | 120 | 114 |
| Not completed | 0 | 0 |
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
| weeks | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Progression-Free Survival (PFS) in the Overall Population | 17.6 (13.4 to 18.9) | 11.9 (11.4 to 15.9) |
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
| weeks | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Progression-Free Survival in the Female Population | 17.9 (14.7 to 22.7) | 13.0 (11.1 to 17.7) |
The OS is defined as the time from date of randomization until death. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (i.e, their status must be known at the censored date and should not be lost to follow up or unknown).
| months | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Overall Survival (OS) | 10.5 (8.9 to 12.3) | 9.2 (7.1 to 12.0) |
The ORR is the number of participants that are responders i.e, those participants with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 6 weeks, progressive disease (PD) or NE.
| percentage of participants | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Objective Response Rate (ORR) | 19.1 | 7.9 |
The DCR is defined as the number of patients who achieved disease control at 6 weeks following randomization. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 6 weeks.
| percentage of participants | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Disease Control Rate (DCR) | 56.6 | 45.7 |
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment).
| weeks | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Duration of Response (DoR) | 24.1 (17.4 to 30.0) | 24.4 (18.0 to 32.0) |
TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.
| weeks | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Time to Deterioration of Disease-Related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score | 18.1 (15.1 to 23.6) | 12.1 (9.7 to 17.3) |
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days. The ASBI is derived from 6 of LCSS's 9 items.
| weeks | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Time to Deterioration of Disease-Related Symptoms by Average Symptom Burden Index (ASBI) Score | 16.0 (14.0 to 20.3) | 13.4 (10.3 to 17.9) |
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all 9 visual analogue participant scales from "none" \[0 millimeter (mm)\] to "as much as it could be" (100 mm).
| mms on a visual analogue scale | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Longitudinal Analysis of Lung Cancer Symptom Scale Total Score | 25.7 ± 2.85 | 28.3 ± 2.77 |
The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the 6 symptom visual analogue patient scales from "none" (0 mm) to "as much as it could be" (100 mm).
| mms on a visual analogue scale | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed |
|---|---|---|
| Longitudinal Analysis of Average Symptom Burden Index Score | 21.7 ± 2.75 | 24.3 ± 2.67 |
Collected over From the date of informed consent up to the study completion for each participant, approximately 193 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized Period: Vandetanib Plus Pemetrexed | 122/260 (46.9%) | 84/260 (32.3%) | 234/260 (90%) |
| Randomized Period: Placebo Plus Pemetrexed | 147/273 (53.8%) | 94/273 (34.4%) | 242/273 (88.6%) |
| Survival Follow-up Period: Vandetanib Plus Pemetrexed | 63/124 (50.8%) | 7/124 (5.6%) | 22/124 (17.7%) |
| Survival Follow-up Period: Placebo Plus Pemetrexed | 58/110 (52.7%) | 3/110 (2.7%) | 19/110 (17.3%) |
| Event | Randomized Period: Vandetanib Plus Pemetrexed | Randomized Period: Placebo Plus Pemetrexed | Survival Follow-up Period: Vandetanib Plus Pemetrexed | Survival Follow-up Period: Placebo Plus Pemetrexed |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 7/260 | 10/273 | 1/124 | 0/110 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 8/260 | 10/273 | 0/124 | 0/110 |
| PyrexiaGeneral disorders | 7/260 | 3/273 | 0/124 | 1/110 |
| AnaemiaBlood and lymphatic system disorders | 2/260 | 7/273 | 0/124 | 0/110 |
| VomitingGastrointestinal disorders | 3/260 | 6/273 | 0/124 | 0/110 |
| FatigueGeneral disorders | 1/260 | 6/273 | 0/124 | 0/110 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 3/260 | 6/273 | 1/124 | 0/110 |
| NeutropeniaBlood and lymphatic system disorders | 2/260 | 5/273 | 0/124 | 0/110 |
| Lower Respiratory Tract InfectionInfections and infestations | 4/260 | 2/273 | 0/124 | 0/110 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 3/260 | 4/273 | 0/124 | 0/110 |
| Event | Randomized Period: Vandetanib Plus Pemetrexed | Randomized Period: Placebo Plus Pemetrexed | Survival Follow-up Period: Vandetanib Plus Pemetrexed | Survival Follow-up Period: Placebo Plus Pemetrexed |
|---|---|---|---|---|
| FatigueGeneral disorders | 99/260 | 118/273 | 2/124 | 2/110 |
| RashSkin and subcutaneous tissue disorders | 99/260 | 71/273 | 3/124 | 1/110 |
| NauseaGastrointestinal disorders | 73/260 | 98/273 | 0/124 | 3/110 |
| DiarrhoeaGastrointestinal disorders | 66/260 | 48/273 | 3/124 | 2/110 |
| CoughRespiratory, thoracic and mediastinal disorders | 66/260 | 59/273 | 4/124 | 3/110 |
| AnorexiaMetabolism and nutrition disorders | 56/260 | 65/273 | 3/124 | 1/110 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 49/260 | 56/273 | 2/124 | 1/110 |
| VomitingGastrointestinal disorders | 37/260 | 55/273 | 3/124 | 3/110 |
| ConstipationGastrointestinal disorders | 52/260 | 53/273 | 3/124 | 0/110 |
| AnaemiaBlood and lymphatic system disorders | 19/260 | 54/273 | 0/124 | 1/110 |
The full analysis set included all randomized participants.
| Age, Continuous(years) | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed | Total |
|---|---|---|---|
| Mean | 58.7 ± 9.95 | 60.2 ± 9.5 | 59.4 ± 9.73 |
| Sex/Gender, Customized(Participants) | Vandetanib Plus Pemetrexed | Placebo Plus Pemetrexed | Total |
|---|---|---|---|
| Female | 97 | 107 | 204 |
| Male | 159 | 171 | 330 |
Showing the first 100 of 110 sites across 21 countries. Choose a country and city above to see the rest.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vandetanib
Carcinoma, Non-Small-Cell Lung →