Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy
CompletedPhase 3Results postedLast updated 11 June 2019
What this trial tests
Phase 3 trial testing Laboratory Biomarker Analysis in Stage IIIB Lung Non-Small Cell Cancer AJCC v7 in 210 participants. Completed in 28 May 2015.
18 and older, any sex, with Stage IIIB Lung Non-Small Cell Cancer AJCC v7 or Stage IV Non-Small Cell Lung Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)
Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
Group
Value
95% CI
Arm I (Sunitinib Malate)
4.3
3.2 – 4.9
Arm II (Placebo)
2.6
1.8 – 3.0
Overall Survival (OS)Secondary· Time from randomization to death (up to 5 years)
Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Arm I (Sunitinib Malate)
11.7
9.9 – 14.0
Arm II (Placebo)
12.1
9.8 – 15.3
Response Rate (RR)Secondary· Duration of treatment (up to 5 years)
The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Group
Value
95% CI
Arm I (Sunitinib Malate)
11
Arm II (Placebo)
5
Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health SubscaleSecondary· At 3 months
The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Group
Value
95% CI
Arm I (Sunitinib Malate)
55.8
Arm II (Placebo)
28.6
Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea SubscaleSecondary· At 3 months
The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Group
Value
95% CI
Arm I (Sunitinib Malate)
31.5
Arm II (Placebo)
29.3
Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Secondary· Duration of study (up to 5 years)
Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
Fatigue
Group
Value
95% CI
Arm I (Sunitinib Malate)
26
Arm II (Placebo)
0
Thrombocytopenia
Group
Value
95% CI
Arm I (Sunitinib Malate)
12
Arm II (Placebo)
0
Hypertension
Group
Value
95% CI
Arm I (Sunitinib Malate)
12
Arm II (Placebo)
0
Rash
Group
Value
95% CI
Arm I (Sunitinib Malate)
11
Arm II (Placebo)
0
Mucositis
Group
Value
95% CI
Arm I (Sunitinib Malate)
11
Arm II (Placebo)
0
Neutropenia
Group
Value
95% CI
Arm I (Sunitinib Malate)
7
Arm II (Placebo)
0
Anemia
Group
Value
95% CI
Arm I (Sunitinib Malate)
6
Arm II (Placebo)
0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 11 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00693992.