An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV NonsmallCell Lung Cancer Tumors with EGFR Activating Mutations (SOLAR Study)
- Conditions
- on-small Cell Lung Cancer Tumors NSCLCMedDRA version: 20.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002894-39-IT
- Lead Sponsor
- ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
Subject must meet all of the following inclusion criteria to be eligible for
participation in this study at enrollment:
1. Institutional Review Board (IRB)/Independent Ethics Committee
(IEC) approved written informed consent and privacy language as per
national regulations (e.g., HIPAA Authorization for U.S. sites) must be
obtained from the subject or legally authorized representative prior to
any
study-related procedures.
2. Subject is = 18 years of age and legally an adult according to local
regulation at the time of signing informed consent.
3. Subject agrees not to participate in another interventional study while
on treatment.
4. Female subject must either:Be of nonchildbearing potential:
- postmenopausal (defined as at least 1 year without any menses) prior
to Screening, or
- documented surgically sterile
Or, if of childbearing potential:
- Agree not to try to become pregnant during the study and for 28 days
after the final study drug administration
- And have a negative serum pregnancy test at Screening
- And, if heterosexually active, agree to consistently use 2 forms of
highly effective birth control* (at least 1 of which must be a barrier
method) starting at Screening and throughout the study period and for
28 days after the final study drug administration
5. Female subject must not be breastfeeding at Screening or during the
study period, and for 28 days after the final study drug administration.
6. Female subject must not donate ova starting at Screening and
throughout the study period, and for 28 days after the final study drug
administration.
7. Male subject and their female spouse/partners who are of
childbearing potential must be using highly effective contraception
consisting of 2 forms of birth control* (1 of which must be a barrier
method) starting at Screening and continue throughout the study period
and for 90 days after the final study drug administration.
*Highly effective forms of birth control include:
- Consistent and correct usage of established oral, injected or implanted
hormonal methods of contraception
- Established intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or occlusive cap (diaphragm
or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository
8. Male subject must not donate sperm starting at Screening and
throughout the study period and for 90 days after the final study drug
administration.
9. Subject has Eastern Cooperative Oncology Group (ECOG) performance
status = 2.
10. Subject has histologically confirmed locally advanced, metastatic or
unresectable Stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or
recurrent). Subjects with mixed histology are eligible if adenocarcinoma
is the predominant histology.
11. Subject has predicted life expectancy = 12 weeks in the opinion of
the investigator.
12. Subject must meet all of the following criteria on the laboratory tests
that will be analyzed centrally within 7 days prior to the first dose of
study drug. In case of multiple laboratory data within this period, the
most recent data should be used.
- Neutrophil count > 1,000/mm^3
- Platelet count = 7.5 x 10^4 /mm^3
- Hemoglobin > 8.0 g/dL
- Serum creatinine < 2.0 x upper limit of normal (ULN) or an estimated
glomerular filtration rate (eGFR) of > 50 mL/min as calculated by the
Cockcroft Gault Method
Total bilirubin < 1.5 x ULN (except for subjects with documented
Gilbert's syndrome)
AST and ALT < 3.0 x ULN or = 5 x ULN if subject has docum
Subject who meets any of the following exclusion criteria prior to
enrollment is not eligible for enrollment:
1. Subject has received intervening anticancer treatment or previous
treatment with chemotherapy
for metastatic disease. The administration of neoadjuvant or adjuvant
chemotherapy is allowed as long as it has finalized = 6 months before
the first dose of study drug.
2. Subject has received a prior treatment with a therapeutic agent
targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc).
3. Subject has received investigational therapy within 28 days or 5 halflives
prior to the first dose of study drug.
4. Subject has received radiotherapy within 1 week prior to the first dose
of study drug. If the subject received radiotherapy > 1 week prior to
study treatment, the irradiated lesion cannot be the only lesion used for
evaluating response.
5. Subject has symptomatic central nervous system (CNS) metastasis.
Subject with previously treated brain or CNS metastases are eligible
provided that the subject has recovered from any acute effects of
radiotherapy and is not requiring escalating doses of steroids, and any
whole brain radiation therapy was completed at least 2 weeks prior to
study drug administration, or any stereotactic radiosurgery (SRS) was
completed at least 1 week prior to the first dose of study drug.
6. Subject has received blood transfusions or hematopoietic factor
therapy within 14 days prior to the first dose of study drug.
7. Subject has had a major surgical procedure (other than a biopsy)
within 14 days prior to the first dose of study drug, or one is planned
during the course of the study.
8. Subject has a known history of a positive test for human
immunodeficiency virus (HIV) infection.
9. Subject has known history of serious hypersensitivity reaction to a
known ingredient of ASP8273, erlotinib or gefitinib.
10. Subject has evidence of an active infection requiring systemic
therapy within 14 days prior to the planned first dose of study drug.
11. Subject has severe or uncontrolled systemic diseases including
uncontrolled hypertension (blood pressure > 150/100 mmHg) or active
bleeding diatheses.
12. Subject has history of drug-induced interstitial lung disease (ILD) or
any evidence of active ILD.
13. Subject has ongoing cardiac arrhythmia that is Grade = 2 or
uncontrolled atrial fibrillation of any
grade.
14. Subject currently has Class 3 or 4 New York Heart Association
congestive heart failure.
15. Subject has history of severe/unstable angina, myocardial infarction
or cerebrovascular accident within 6 months prior to the planned first
dose of study drug.
16. Subject has history of gastrointestinal ulcer or gastrointestinal
bleeding within 3 months prior to the planned first dose of study drug.
17. Subject has concurrent corneal disorder or any ophthalmologic
condition which, in the investigator's opinion, makes the subject
unsuitable for study participation (i.e., advanced cataracts, glaucoma).
18. Subject has difficulty taking oral medication or any digestive tract
dysfunction or inflammatory bowel disease that would interfere with the
intestinal absorption of drug.
19. Subject has another malignancy which requires treatment.
20. Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.
21. Subject has used the following drugs:
a. Potent CYP 3A4 inhibitors within 7 days prior to first dose of study
drug
b. Proton pump inhibitors such as omeprazole w
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -T-o evaluate the progression free survival (PFS), based on independent<br>radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in<br>patients with locally advanced, metastatic or unresectable stage IIIB/IV<br>adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal<br>growth factor receptor (EGFR) activating mutations.;Secondary Objective: - Overall survival (OS)<br>- Overall response rate (ORR) as assessed by IRR<br>- PFS as assessed by the investigator<br>- Disease control rate (DCR) as assessed by IRR<br>- Safety of ASP8273;Primary end point(s): - PFS as assessed by IRR;Timepoint(s) of evaluation of this end point: Up to 36 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - OS<br>- Best overall response rate (CR + PR) by IRR<br>- PFS by the investigator<br>- DCR (CR+PR+SD) by IRR<br>- Safety variables (e.g., adverse events [AEs], laboratory tests, vital sign<br>measurements, electrocardiograms [ECGs]);Timepoint(s) of evaluation of this end point: Up to 36 months