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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77341241

Enrollment

514

Registered

2003-07-02

Start date

2003-01-01

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer Cancer Malignant neoplasm of lung

Interventions

Patients on the trial will receive up to 4 cycles of gemcitabine and carboplatin at 3 weekly intervals. Patients will be randomised to receive either thalidomide or placebo daily beginning on day 1 fo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026