A randomized phase II study of erlotinib compared to single agent chemotherapy-erlotinib combination in pretreated patients with advanced NSCLC (NVALT10 study) - NVALT10

• Conditions: patients who failed previous cytotoxic treatment for non-small-cell lung cancer locally advanced and metastatic disease stage IIIB and IV; MedDRA version: 9.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIB; MedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IV

• Registration Number: EUCTR2009-009315-22-NL
• Lead Sponsor: VALT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-08
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1.Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
2.Complete recovery from prior chemotherapy side effects to < Grade 2.
3.At least one unidimensionally measurable lesion meeting RECIST criteria.
4.ECOG PS 0-2.
5.Age > 18 years.
6.Adequate organ function, including:
a.Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
b.Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 1.5 x ULN
AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
c.Renal: calculated creatinin clearance > 40 ml/min based on the Cockroft-Gault formula.
7.Estimated life expectancy >12 weeks.
8.Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
9.Signed informed consent.
10.Patient compliance and geographical proximity that allow adequate follow up.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating women.
2.Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
3.Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
4.Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
5.Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
6.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethason.
7.Concomitant treatment with any other experimental drug under investigation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to compare progression free survival between erlotinib and a cytotoxic agent-erlotinib combination in patients who failed previous cytotoxic treatment for NSCLC locally advanced and metastatic disease stage IIIB and IV. Pemetrexed was chosen as cytotoxic agent in non-squamous cell carcinoma was chosen and docetaxel in squamous cell carcinoma.;Secondary Objective: Toxicity.;Primary end point(s): Progression free survival.