A multicentre, double-blind randomised, phase III study to evaluate the efficacy of Tarceva or placebo following 4 cycles of platinum-based chemotherapy in patients with histologically documented advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who have not experienced disease progression or unacceptable toxicity during chemotherapy. - SATUR

Phase 1

• Conditions: Advanced (stage IIIB or IV) NSCLC previously treated with 4 cycles of a platinum-based chemotherapy

• Registration Number: EUCTR2005-002241-39-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-13
• Study Completion: 2010-11-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 854

Inclusion Criteria

- Patients with histologically documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer and who meet the study selection criteria).
Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy. This Is A Mandatory Requirement For Study Entry.
- Patients must have measurable disease according to the RECIST criteria (in addition to investigator review, all CT/MRI data will in addition be reviewed by a central reader as confirmatory process). NOTE: Patients who experience CR, PR or SD during chemotherapy are eligible for the Tarceva/placebo study.
- Previous adjuvant or neo-adjuvant treatment is permitted if completed >= 6 months before start of the chemotherapy phase.
- ECOG performance status of 0 – 1.
- Written (signed) Informed Consent for use of tumour samples.

- Completion, of 4 cycles of an acceptable, standard, platinum based chemotherapy doublet without progression (i.e. CR, PR or SD). This Is A Mandatory Requirement For Study Entry. A maximum interval of 21 days between end of the last chemotherapy cycle and randomisation will be allowed.
- ECOG performance status of 0 - 1.
- Life expectancy of at least 12 weeks.
- Patients must be able to take oral medication.
- At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study.
- Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin >= 9.0g/dl.
- SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases.
- Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is >= 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN. If alkaline phosphatase is >= 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
- Serum creatinine =< 1.5 ULN or creatinine clearance > 60 ml/min.
- Normal serum calcium.
- For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
- Male and Female patients with reproductive potential must use 2 effective methods of contraception.
- Age 18 (or legal age of consent if greater than 18) or greater.
- Able to comply with study and follow-up procedures.
- Written (signed) Informed Consent to participate in the randomised part of the study.
- Patients must be able to effectively read, and understand the local language(s) for which the FACT-L questionnaires are available.
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

- No prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzomab).
- No prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted.
- Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
- Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded.
- Patients who are at risk (in the investigator’s opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
- Any inflammatory changes of the surface of the eye.
- Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- Nursing and/or pregnant women.
- Hypersensitivity to erlotinib (Tarceva) or to any of the excipients.

Study & Design

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