Evaluation of the efficacy of high throughput genome analysis as a therapeutic decision tool for patients with metastatic non small cell lung cancer - SAFIR 02 Lung

• Conditions: Patients with metastatic non small cell lung cancer (NSCLC) in 1st line chemotherapy; MedDRA version: 18.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001653-27-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-16
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who received 4 cycles of an induction platinum-based chemotherapy and who are presenting a stable or a responding disease at the time of randomization
2. Patients who still meet the screening phase inclusion (except criteria 4) and exclusion criteria (except criteria 2)
3. Patients whose tumor sample is presenting at least one genomic alteration from the list of predefined targetable genomic alterations and for whom the multidisciplinary tumor board has provided a personalized guidance
4. Age > 25 years for patients planned to receive AZD4547
5. Patients will have had at least a 28-day washout period from the platinum-based regimen prior to randomization and should have recover (grade =1) from all residual toxicities, excluding alopecia.
6. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, beginning 2 weeks before the first dose of investigational product and for at least 3 months after the last dose of study drug.
7. Women of childbearing potential must have a negative serum pregnancy test done within 14 days and/or urine pregnancy test 72 hours prior to the administration of the study drug
8. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 3 months after the last dose.
9. Provision of signed and dated, written informed consent prior to randomization and to any study specific procedures, sampling and analyses
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 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

Exclusion Criteria

1. No targetable” genomic alteration identified during the screening phase (either due to the lack of alteration or due to ineligible samples for genomic analysis) or unfavorable decision from the multidisciplinary tumor board to drive the patient to the randomization
2. Life expectancy < 3 months.
3. Disease progression or toxicity that led to the discontinuation of the platinum-based chemotherapy before 4 full cycles have been delivered, or disease progression occurring between the end of chemotherapy and randomization
4. Major surgery within 30 days (excluding placement of vascular access) or minor surgery within 14 days prior to randomisation
5. Less than 28 days from radiotherapy (wide field of radiation), less than 2 weeks from palliative radiation (limited fields). Fields should not have involved all target lesions
6. Patients previously treated in the last 30 days with a targeted agent in the same class as agents tested in this study
7. Participation to another clinical study with an investigational product (IP) during the last 30 days
8. History of hypersensitivity to active or inactive excipients of one of the study drugs
9. Toxicities of grade =2 from any previous anti-cancer therapy, with the exception of alopecia
10. Altered haematopoietic or organ function, as indicated by the following criteria:
- Polynuclear neutrophils < 1.5 x 109/L
- Platelets < 100 x 109/L
- Haemoglobin < 90 g/L
- ALAT/ASAT > 2.5x ULN in the absence of or > 5x ULN in the presence of liver metastases
- bilirubin > 1.5xULN
- creatinine clearance =50 mL/min (measured or calculated by Cockroft and Gault formula)
- Proteinuria > 3+ on dipstick analysis or > 3.5g/24 hours or a urine protein/creatinine ratio > 3.5 (only for patients dried to receive AZD5363)
- Sodium, magnesium, calcium and phosphate > ULN
- Potassium < 4 mmol/L
- glycosylated haemoglobin (HbA1C) = 8.0% (64 mmol/mol), (only for patients dried to receive AZD5363)
- Fasting Plasma Glucose = 7.0 mmol/L(126 mg/dL) (fasting is defined as no calorie intake for at least 8 hours)
11. Any of the following additional cardiac criteria:
- Mean resting corrected QT interval (QTc)>480msec (or QTcF >450 msec) obtained from 3 consecutive ECGs
- LVEF <50% (MUGA scan or Echocardiogram),
12. Altered ophthalmic conditions confirmed by an ophthalmology specialist for patients likely to be treated with :
- AZD4547 : current evidence or previous history of retinal pigmented epithelium detachment (RPED), previous laser treatment or intra-ocular injection for treatment of macular degeneration, current evidence or previous history of dry or wet age-related macular degeneration, current evidence or previous history of retinal vein occlusion (RVO), current evidence or previous history of retinal degenerative diseases (eg, hereditary), current evidence or previous history of any other clinically relevant chorioretinal defect
- AZD8931 : any eye injury in the previous 3 months or a prior eye injury still associated with persistent or recurrent symptoms or impairment of vision, corneal surgery (laser refractive surgery performed more than 3 months prior to the start of the trial is allowed and should be recorded in surgical history), orbital irradiation, collagen vascular, chronic inflammatory or degenerative disease with eye involvement (eg, rheumatoid, Sjögren’s syndrome, systemic lupus erythematosus [SLE]), clinically significant ocular surface disease i.e. diseases of the conjunctiva an

Study & Design

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