Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

NSCLC Clinical Trial

Official title:

Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777179
• Other study ID #: D4200C00077
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2008
• Last updated: August 14, 2012
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.

• Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.

• WHO PS 0-1

• No prior radiotherapy to chest, immunotherapy or biologic therapy

Exclusion Criteria:

• Mixed small cell and non small-cell lung cancer history.

• Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is not permitted.)

• Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.

• Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• NSCLC

Intervention

Drug:
• Vandetanib
Tablet, oral, daily
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Research Site	CheongJu	Republic of Korea
Korea, Republic of	Research Site	Gyeonggi-do	Republic of Korea
Korea, Republic of	Research Site	Gyeongsangnam-Do	Republic of Korea
Korea, Republic of	Research Site	Incheon	Republic of Korea
Korea, Republic of	Research Site	Seoul	Republic of Korea

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Rate at 3 Months	Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.	12 weeks	No
Secondary	Progression-free Survival (PFS)	Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.	Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.	No
Secondary	Overall Survival (OS)	Overall survival (OS) defined as the median time from randomization to death from any cause.	Every 12 weeks unless the patient withdraws consent	No
Secondary	Disease of Response (DOR)	Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.; Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response	Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.	No
Secondary	Objective Response Rate (ORR)	Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.; Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.	Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.	No