A study to investigate Patritumab in combination with Erlotinib in patients with lung cancer.
- Conditions
- on-Small Cell Lung Cancer (NSCLC)MedDRA version: 17.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004371-12-ES
- Lead Sponsor
- Daiichi Sankyo Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 780
Subjects must satisfy all of the following criteria to be included in the study:
1. Must be >= 20 years of age
2. Must have histologically confirmed NSCLC with either:
a) Metastatic disease (Stage IV) OR
b) Stage IIIB disease not amenable to surgery or curative intent.
Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0 staging system. For sites that use AJCC Version 7.0, T4M0 patients with other ipsilateral nodules and N0-N2 are still eligible.
3. If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes the exon 19 deletion and the exon 21 (L858R) substitution.
- Historical locally generated EGFR results may be acceptable if assay details are available. Historical EGFR test results for all subjects with adenocarcinoma must be provided to the Sponsor's designee for confirmation prior to randomization. See Laboratory Manual for details.
- Archived tumor samples from patients without a verified historical result will be tested by the sponsor at the central testing lab. See Laboratory Manual for instructions on archived tumor sample submission.
4. Must have received one or two prior lines of systemic anticancer therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy
- Patients who received only adjuvant systemic treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy.
- For patients who received adjuvant systemic therapy and subsequent systemic therapy for metastatic disease, the adjuvant treatment counts as a line of therapy only if disease progression occurred < 6 months after its completion.
- Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
5. Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
6. Must have available recent (before treatment start) or archival tumor specimen meeting these criteria:
- Part A subjects: Recent or archival tumor specimens must be determined by the central pathology laboratory to be HRG high or low using the validated IUO-1 assay. (Refer to the Laboratory Manual for details on specimen requirements). Subjects with undetermined HRG expression will be excluded.
- Part B subjects: Recent or archival tumor specimens must be HRG high as determined by the central pathology laboratory using IUO-2. (Refer to the Laboratory Manual for details on specimen requirements). Subjects with undetermined HRG expression will be excluded.
7. Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines Version 1.1 for Part A; for Part B, must have measurable disease or non-measurable disease per RECIST
8. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. Must have adequate hematological function, as follows:
- ANC >= 1.5 x 109/L
- Platelet count >= 100 x 109/L
- Hemoglobin >= 9 g/dL
10. Must have adequate renal function, as follows:
- Calculated creatinine clearance >= 60 mL/min using the modified Cockroft-Gault equation
- Serum creatinine <= 1.5 x ULN
11. Must have adequate hepatic function, as follows:
- AST <= 2.5 x ULN (if liver metastases are present, < 5 x ULN)
- ALT <= 2.5 x ULN (if liver metastases are
Subjects who meet any of the following criteria will be disqualified from entering the study:
1. Lung adenocarcinoma with an ALK gene rearrangement. Test results for all subjects with adenocarcinoma must be provided to the Sponsor's designee for confirmation prior to randomization. Refer to the Laboratory Manual for further details on sample and testing requirements.
a. Historical locally generated results may be acceptable if assay details are available. Historical ALK test results for all subjects with adenocarcinoma must be provided to the Sponsor's designee for confirmation prior to randomization. See Laboratory Manual for details.
b. Archived tumor samples from patients without a verified historical result will be tested by the sponsor at the central testing lab. See laboratory manual for instructions on archived tumor sample submission.
2. Left ventricular ejection fraction (LVEF) < 45%
3. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for >= 5 years
5. History of corneal disease
6. History of interstitial lung disease (ILD)
7. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy and have no evidence of disease progression on imaging studies (MRI/CT scan). A minimum of 4 weeks (2 weeks for subjects with a solitary brain lesion amenable to stereotactic radiosurgery) must have elapsed between the end of radiotherapy and study enrollment.
8. Uncontrolled hypertension (diastolic > 100 mmHg or systolic > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within required parameters.
9. Clinically significant ECG changes that obscure the ability to assess the RR, PR, QT, QTc, and QRS intervals.
10. Clinically significant (any grade) ascites or pleural effusion requiring chronic medical intervention
11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment; treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small molecule TKIs within 2 weeks before study drug treatment
Prior and concurrent use of hormone replacement therapy is permitted.
13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment. No target lesion should be selected within the previously irradiated field unless there was progression at that lesion following radiation.
14. Participation in clinical drug trials within 4 weeks (2 weeks for small molecule TKIs) before study drug treatment, or current participation in other investigational procedures
15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, kn
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