A phase II/III randomised, double blind, placebo controlled trial of gemcitabine/carboplatin with or without thalidomide in advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Completed

• Conditions: on-small cell lung cancer; Cancer; Malignant neoplasm of lung

• Registration Number: ISRCTN77341241
• Lead Sponsor: Sponsor not defined - Record supplied by London Lung Cancer Group

Brief Summary

2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19770378 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-07-02
• Study Completion: 2005-09-07
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

1. Histologically or cytologically confirmed NSCLC, stage IIIb or IV
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and estimated life expectancy of at least 8 weeks
3. Adequate renal function and bone marrow reserve
4. Women Of Childbearing Potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use TWO methods of contraception while on study medication, and have a negative serum or urine pregnancy test within the 24 hours before starting study medication. Those who are sexually active in a heterosexual relationship must agree to have pregnancy tests every 4 weeks while on study medication and 4 weeks after the last dose of study medication
5. Male patients (including those who have had a vasectomy) must use barrier contraception when engaging in heterosexual activity with WCBP while on study medication and 4 weeks after the last dose

Exclusion Criteria

1. Pregnant or lactating women or WCBP not using adequate contraception
2. Prior treatment with chemotherapy or radiotherapy
3. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
4. Prior history of thromboembolic event (including: Pulmonary Embolism [PE], Deep Vein Thrombus [DVT], Cerebro-Vascular Accident [CVA]/Transient Ischaemic Attack [TIA])
5. Symptomatic brain metastases thought to require immediate radiotherapy
6. History of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration