Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01146756
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC either inoperable, stage III NSCLC or stage IV NSCLC with dominant chest symptoms.
* Patient age ≥18
* Willingness and able to comply with treatment, tests and attend the required follow-up
* Prior chemotherapy is permitted provided the interval between day 8 of the last cycle of chemotherapy and day 1 of AZD6244 dosing is ≥2 weeks
* No prior radiotherapy or investigational agents
* Life expectancy estimated to be greater than 3 months
* Performance status(ECOG) 0 or 1
* MRC dyspnoea score \<3
* Patient considered able to tolerate radical radiotherapy
* FEV1 \>40% of predicted and DLCO (transfer factor for carbon monoxide) \>40% of predicted
* Disease which can be encompassed within a radical radiotherapy treatment volume(V20 ≤35% and maximum cord dose 48Gy) on the radiotherapy planning scan
* Left ventricular ejection fraction \>50% on baseline echocardiogram
* Adequate renal function - defined by GFR \>50 ml/min (calculated Cockcroft and Gault) or by isotope GFR.
* Adequate bone marrow reserve: white cell count \>3 x 109/l, absolute neutrophil count \>1.5 x 109/l, haemoglobin \>10.0 g/dl and platelet count \>100 x 109/l (Blood transfusion permitted to achieve Hb \>10g/dl)
* AST/ALT \< 2.5 ULN and bilirubin \<1.5 ULN
* Group D (expanded cohort) only: diameter of the primary tumour should be \> 2 cm
Exclusion Criteria:
* Mixed non-small cell and small cell tumours
* Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
* Lack of recovery from prior chemotherapy toxicity to grade ≤2 except alopecia d)Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption of AZD6244
* Presence of clinically significant fluid accumulations in third spaces which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study.
* History / evidence of active bleeding diatheses
* History of unstable diabetes
* History of interstitial pneumonitis
* Arterial hypertension defined as SBP≥ 160 or DBP ≥100 (antihypertensive medication to achieve these parameters are permissible)
* Myocardial infarction, or unstable or uncontrolled angina, congestive heart failure (NYHA \> class II) within 1 year of enrollment
* Active infection on day of enrollment
* Uncontrolled hypercalcemia \>3.0 or symptomatic
* History of hypersensitivity to active or inactive excipients of AZD6244
* Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment
* Known and symptomatic brain metastases. Brain imaging is not mandatory if patient is asymptomatic.
* Clinical judgement by the investigator that the patient should not participate in the study
* Patients of reproductive potential who are unable to comply with effective contraception if sexually active during the study and for a period of at least 90 days (men) or 6 months after treatment (women)
* Women who are breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01146756
Study Brief:
Protocol Section:
NCT01146756