Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Investigational treatment (pazopanib and pemetrexed)

Standard treatment (pemetrexed and cisplatin)

oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m\^2 once every 3 weeks, then pazopanib 800 mg once daily

pazopanib and pemetrexed

pemetrexed IV 500 mg/m\^2 and cisplatin IV 75 mg/m\^2 once every 3 weeks

pemetrexed and cisplatin

GSK Clinical Trials

The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).

Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer

PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).

OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.

Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.

The percentage of participants with a complete response or a partial response was evaluated.

GlaxoSmithKline

Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.

Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.

Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2

Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.

Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2

IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.

Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2

Total

Age Continuous

Sex: Female, Male

African American/African Heritage

Asian - Central/South Asian Heritage

White - Arabic/North African Heritage

White - White/Caucasian/European Heritage

Race/Ethnicity, Customized

Efficacy data were only summarized for the pazopanib (pazo.) 800 mg + pemetrexed (peme.) 500 mg/m\^2 and the cisplatin 75 mg/m\^2 + peme. 500 mg/m\^2 arms due to the small sample size/short treatment duration in the pazo. 600 mg + peme. 500 mg/m\^2 arm.

GSK Response Center

Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

Progression-free Survival (PFS)

Overall Survival (OS)

Complete response

Partial response

Stable disease

Progressive disease

Unknown

ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.

Spots Global Cancer Trial Database for Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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