Randomized Clinical Trial of Maintenance Therapy with Immunomodulator MGN1703 in Patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy
- Conditions
- Small Cell Lung CancerMedDRA version: 19.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003503-19-DE
- Lead Sponsor
- Mologen AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Male and female patients with extensive disease SCLC = 18 years of age receiving platinum-based first-line chemotherapy;
2. Extensive disease SCLC confirmed by a pathologist, on the basis of
histology of SCLC or mixed histology of SCLC, or a cytological diagnosis if
histology cannot be obtained;
3. Completion of 4 cycles of first-line therapy with a platinum-based regimen and no other prior chemotherapy;
4. Documented evidence of tumor response (PR or CR) as assessed by the investigator at the end of the fourth cycle of platinum-based first-line chemotherapy using CT or magnetic resonance imaging (MRI) scan;
5. Brain metastases are allowed only after cranial irradiation, if asymptomatic and not requiring continuous treatment with steroids or anticonvulsants. MRI of the brain should be performed in all patients at Screening;
6. ECOG performance status 0 or 1;
7. Adequate organ function with total bilirubin, lactate dehydrogenase [LDH], alkaline phosphatase [AP], albumin, creatinine, urea, electrolytes, and coagulation parameters = 1.5 × upper limit of normal (ULN), and with aspartate aminotransferase [AST] and ALT = 2.5 × ULN in the absence of liver metastases or = 5.0 × ULN in the presence of liver metastases;
8. Adequate hematological parameters: absolute neutrophil count = 1.0 × 109/L; platelet count = 80 × 109/L; leukocyte count = 2.0 × 109/L; lymphocytes = 0.8 × 109/L; hemoglobin = 9.0 g/dL or 5.59 mmol/L;
9. Male patients who have had vasectomy, and female patients who are not of childbearing potential (i.e. who are post-menopausal for at least 24 consecutive months or who have undergone surgical sterilization [hysterectomy, bilateral tubal ligation, or bilateral oophorectomy]). Male and female patients with reproductive potential can be included if they are using an effective means of contraception with a failure rate of less than 1% per year throughout the study, e.g. established use of oral, implanted, or injected hormonal contraceptives; placement of intra-uterine device or intra-uterine system; or use of barrier methods such as condom or diaphragm together with spermicide product;
10. Negative serum pregnancy test in women of childbearing potential;
11. Signed informed consent form (ICF).
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Patients with no evidence of tumor response (PR or CR) at the end of the fourth cycle of platinum-based chemotherapy;
2. Clinically significant concomitant diseases or conditions, which, in opinion of the investigator, would lead to an unacceptable risk for the patient to participate in the study;
3. Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for more than 3 years;
4. History of carcinomatous meningitis;
5. Prior or current paraneoplastic syndrome related to SCLC;
6. Active or uncontrolled infections at the time of randomization;
7. Severe anemia requiring repeated blood cell transfusion;
8. History of autoimmune disease or immune deficiency;
9. Known hypersensitivity to oligonucleotides or excipients of the formulation;
10. Pregnant and/or nursing;
11. Chronic systemic immune therapy or immunosuppressant medication
other than steroids within the last 6 weeks prior to study treatment. If
the patient receives systemic steroids at the time of Screening, the dose
of systemic steroids should gradually be reduced before start of
treatment in the experimental arm;
12. Concurrent use of molecular targeted therapy;
13. HIV seropositivity or active hepatitis B or C infection;
14. Planned major surgery during the study, except for thoracotomy;
15. Participation in another clinical study with other investigational drugs within 28 days prior to study treatment, or treatment with any anti-cancer investigational drug within 12 months prior to study treatment;
16. Vaccination within 1 month prior to study treatment;
17. Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
18. Presence of drug and/or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The overall purpose of the study is to evaluate efficacy and safety of MGN1703 administered twice weekly s.c. as switch maintenance treatment in patients with extensive disease SCLC who achieved at least PR following platinum-based first-line chemotherapy;Secondary Objective: Not applicable;Primary end point(s): Overall survival from the date of randomization;Timepoint(s) of evaluation of this end point: End of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Overall survival from the start of the first cycle of induction chemotherapy (OS1);<br>• Progression-free survival from the date of randomization with progression assessed by RECIST 1.1 and irRC;<br>• Progression-free survival from the start of the first cycle of induction chemotherapy (PFS1) assessed by RECIST 1.1 and irRC;<br>• Best objective response rate (ORR) with clinical response assessed by RECIST 1.1 and irRC;<br>• Quality of life (QoL) measured by Lung Cancer Symptom Scale (LCSS) at every staging;<br><br><br>The following safety assessments are considered as secondary endpoints:<br>• Safety profile of MGN1703 in terms of the incidence of AEs graded according to NCI CTC Version 4.03;<br>• Autoimmunity of MGN1703 in terms of ANA.<br>;Timepoint(s) of evaluation of this end point: End of study