NCT00801736

Brief Summary

Lung cancer is the leading cause of cancer death in the UK, leading to 34 000 deaths each year (22% of cancer deaths). Non-small cell lung cancer (NSCLC) is the most common histology, accounting for approximately 80% of cases and most present with advanced, stage IIIb or IV disease. The recommended treatment for advanced disease is a doublet platinum-based chemotherapy, although the survival benefits are modest. Even among those fit enough for chemotherapy, the response rate is only 20-40%, and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen (Schiller et al, 2002; Rudd et al, 2005; Lee et al, 2007). Only 11% of patients went on to survive 2 years when treated with the newer gemcitabine/carboplatin regimen established by the London Lung Cancer Group (Rudd et al, 2005; Lee et al, 2007). New strategies are needed to further improve the prognosis of this disease.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
648

participants targeted

Target at P75+ for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

December 2, 2008

Last Update Submit

December 9, 2013

Conditions

Lung Cancer

Keywords

Recurrent non-small cell lung cancerStage IIIB non-small cell lung cancerStage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Dec 2014

Secondary Outcomes (1)

  • Time to progression

    Dec 2014

Study Arms (2)

Platinum Arm

EXPERIMENTAL

Cisplatin (IMP) / Pemetrexed (IMP)

Drug: Cisplatin, Paclitaxel

Non Platinum Arm

EXPERIMENTAL

Paclitaxel (IMP) / Pemetrexed (IMP)

Drug: Cisplatin, Paclitaxel

Interventions

Cisplatin, PaclitaxelDRUG

* Cisplatin 75mg/m2, Day 1 * Paclitaxel 175mg/m2, Day 1

Non Platinum ArmPlatinum Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological confirmation of non-squamous NSCLC
  • Have a tissue biopsy available for sending to the central laboratory to determine ERCC1 status
  • Presentation with stage IIIb (not amenable to curative treatment) or IV disease - staging scans must be no more than 28 days prior to registration. Patients with relapsed NSCLC must not have received prior chemotherapy or biological therapy (previous surgery or radical radiotherapy allowed)
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours
  • Either sex, at least 18 years of age
  • ECOG performance status 0-1
  • Estimated life expectancy of at least 8 weeks
  • Adequate bone marrow function as evidenced by the following (assessed within 14 days of registration):
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L
  • Platelet count ≥100 × 109/L
  • Haemoglobin ≥9 g/dL
  • Adequate liver function as evidenced by the following (assessed within 14 days of registration):
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate transaminase (AST) ≤3 × ULN or ≤5 × ULN is acceptable with liver metastases
  • Alanine transaminase (ALT) ≤3 × ULN
  • +6 more criteria

You may not qualify if:

  • Cytologically or clinically diagnosed NSCLC
  • Evidence of significant medical condition or laboratory finding which, in the opinion of the treating physician or chief investigator, makes it undesirable for the patient to participate in the trial
  • Presence of uncontrolled brain or leptomeningeal metastases thought to require immediate radiotherapy
  • Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to trial entry
  • Yellow fever vaccination received within the 30 days previous to study entry
  • Unable to interrupt aspirin or other NSAIDs (for pemetrexed arms of the trial)
  • Unable or unwilling to take vitamin B12 and folic acid (for pemetrexed arms of the trial)
  • A 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
  • Pregnant or lactating women
  • Inability to comply with protocol or trial procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospitals

London, United Kingdom

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Siow M. Lee, MD, PhD, FRCP

    Cancer Research UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

October 1, 2009

Primary Completion

July 1, 2013

Last Updated

December 10, 2013

Record last verified: 2012-12

Locations

GB(1)