Study with investigational drug PF-06463922 in patients with a specific type of advanced lung cancer
- Conditions
- Anaplastic Lymphoma Kinase (ALK)-positive (ALK+) or ROS oncogene 1 (ROS1)-positive (ROS1+) advanced non-small cell lung cancer (NSCLC).MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002620-17-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 332
1. Evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT-PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). A central laboratory confirmation by a Sponsor-selected, validated test will retrospectively determine final ROS1 status. All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
2. Disease Status Requirements
Phase 1: ALK+ positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ALK inhibitor therapy(ies). ROS1+positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ROS1 inhibitor therapy(ies).
Phase 2: ALK positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease progression after 1 or 2 previous ALK inhibitor therapy(ies) as the last therapy given. ROS1 positive NSCLC patients must either be treatment naïve in the advanced setting or have had disease
progression after 1 or 2 previous ROS1 inhibitor therapy(ies) as the last therapy given.
3. Tumor Requirements:
Phase 1: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have asymptomatic radiologically suspected leptomeningeal disease (LM) or carcinomatous meningitis (CM) and negative spinal fluid (CSF) are eligible to enter Phase 1.
Phase 2: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. The brain metastases may be newly diagnosed or be present as progressive disease after surgery, whole brain radiotherapy or stereotactic radiosurgery (see Exclusion Criterion #3 for the lapsed time period required between the end of radiotherapy and study entry). Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) will be eligible if the LM/CM is visualized on MRI or if documented baseline cerebral spinal fluid (CSF) positive cytology is available.
4. Age >=18 years.
5. ECOG Performance Status (PS):
- Phase 1: 0 or 1;
- Phase 2: 0, 1, or 2.
6. Adequate Bone Marrow Function, including:
- Absolute Neutrophil Count (ANC) >=1.5 x 109/L;
- Platelets >=100 x 109/L;
- Hemoglobin >=9 g/dL.
7. Adequate Pancreatic Function, including:
- Serum total amylase within normal limits per local laboratory ranges. If not within normal limits, then pancreatic isoenzyme must be <1.5 ULN.
- Serum lipase <=1.5 ULN.
8. Adequate Renal Func
1.Spinal cord compression is excluded unless the patient demonstrates good pain control attained through therapy and there is stabilization or recovery of neurological function for the 4 weeks prior to study entry
2.Major surgery within 4 weeks of study entry.Minor surgical procedures are not excluded but sufficient time should have passed for wound healing
3.Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry.Palliative radiation (<=10 fractions) must have been completed at least 48 hours prior to study entry.Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry.Whole brain radiation must have completed at least 4 weeks prior to study entry
4.Systemic anti-cancer therapy completed within a minimum of 5 half lives of study entry
5.Previous high-dose chemotherapy requiring stem cell rescue
6.Prior irradiation to >25% of the bone marrow
7.Active and clinically significant bacterial, fungal, or viral infection including HBV, HCV, known HIV or AIDS-related illness
8.Any one of the following currently or in the previous 3 months: myocardial infarction,congenital long QT syndrome,Torsades de Pointes,arrhythmias,right bundle branch block and left anterior hemiblock (bifascicular block),unstable angina,coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,transient ischemic attack or symptomatic pulmonary embolism not adequately medically managed with anticoagulants;as well as bradycardia defined as <50 bpms.Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2,symptomatic atrial fibrillation of any grade,or QTc interval <=481 msec at screening.Right bundle branch block
9.Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (see protocol for more details).
10.History of extensive,disseminated,bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersentivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis. Patients with history of prior radiation pneumonitis are not excluded
11.Participation in other NSCLC treatment studies (i.e. date of last treatment dose) within 2 weeks prior to study entry
12.Other severe acute or chronic medical or psychiatric condition,including recent (within the past year) or active suicidal ideation or behavior,or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and,in the judgment of the investigator,would make the patient inappropriate for entry into this study
13.Patients who are investigational site staff members directly involved in the conduct of the trial and their family members,site staff members otherwise supervised by the Investigator,or patients who are Pfizer employees directly involved in the conduct of the trial
14.Evidence of active malignancy within the last 3 years. See protocol for more details
15.Active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease or previous gastric resection or lap band. Gastroesophageal reflux disease under treatment with proton-pump inhibitors is allowed
For more exclusion criteria refer to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method