ITAC 2 TRIAL: INTERMITTENT TKI AND CHEMOTHERAPY FOR PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER - ITAC 2

Phase 1

• Conditions: The study population consists of patients aged 18 years and older who have histologicaly or cytologicaly proven locally advanced or metastatic NSCLC with activating mutation of EGFR, chemonaive and without prior treatment with TKIs who fullfill all eligibility criteria.TreatmentInvestigational treatment consists of 4 to 6 initial 3-weekly cycles of chemotherapy with gemcitabine-cisplatin and intermittent erlotinib, followed by maintenance treatment with erlotinib.

• Registration Number: EUCTR2010-023362-44-SI
• Lead Sponsor: Institute of oncology Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

For inclusion in the study, patients should meet the following criteria:
•patient's understanding of the disease and treatment and signed written informed consent
•age 18 years or older
•histo-pathological or cytological diagnosis of non-small cell lung cancer of non-squamous type
•positive for mutation of EGFR
•disease stage IV (Stage IV a or IV b) and unsuitable for surgical treatment or for radiotherapy with curative intent
•no history of other malignancy; or in complete remission for > 3 years if previously treated for other malignancy
•chemo-naïve; or more than 3 years after chemotherapy for other cancer; or received not more than 1 cycle of chemotherapy for this cancer
•no previous treatment with TKIs
•if previously treated by radiotherapy, all acute radiation-related toxicity has resolved and the interval is > 2 weeks for total dose = 30 Gy or > 10 days for total dose < 30 Gy
•no clinical symptoms of brain metastases. Patients after surgery and/or radiotherapy for brain metastases and patients with asymptomatic small (< 2 cm) brain metastases are eligible if they meet other eligibility criteria
•according to clinical presentation, no indication for radiotherapy is foreseen until eventual progression of the disease. An exception to this rule are patients with asymptomatic small brain metastases who may be treated with whole-brain radiotherapy in fractions not greater than 2.5 Gy during maintenance treatment with erlotinib (i.e. after completion of 4 cycles of gemcitabine/cisplatin + erlotinib)
•measurable and previously unirradiated disease. Bone metastases as the only measurable lesions are not eligible
•performance status = 70% (Karnofsky); or ECOG 0 – 2
•hemoglobin > 100 g/L
•neutrophils > 2.0 g/L
•platelets > 100 x 109 /L
•kidney function: creatinine within normal limits + ECC > 60 mL/min; or ECC > 100 mL/min
•liver function: bilirubin < 1.25 x UNL; AST/ALT < 2 x UNL (in case of liver metastases AST/ALT < 5 x UNL)
•cardiac compensation

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

Exclusion criteria
•Stage IV a or IV b with solitary metastasis considered for surgery and/or radiotherapy with curative intent
•peripheral neuropathy grade 2 or more (common toxicity criteria – CTC, NCI), unless mechanical in origin
•vascular disease grade 2 or more (CTC)
•active infection or other serious concomitant disease;
•treatment with unapproved medicinal product within 30 days prior to start of study treatment
•pregnancy, breastfeeding, or refusal of using acceptable methods of birth control throughout the study to prevent pregnancy.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives is response rate: proportion of patients in complete remission (CR), partial remission (PR), minimal response and stable disease (SD) and progression (Prog), assessed according to RECIST ;Secondary Objective: Secondary objectives are:<br>•time to tumor progression (TTP) – clinical and/or radiologic progression according to RECIST <br>•overall survival <br>•metabolic response to treatment – comparison of PET-CT uptake before treatment, on day 140 – 160 and on day 360 – 380 after start of treatment <br>•toxicity <br>•quality of life. <br>;Primary end point(s): The primary objectives is response rate: proportion of patients in complete remission (CR), partial remission (PR), minimal response and stable disease (SD) and progression (Prog), assessed according to RECIST