cancer small-cell lungcancer
Conditions
Interventions
Reference therapy: Durvalumab plus carboplatin/etoposide
Investigational therapy: Durvalumab plus carboplatin/etoposide and TRT
Sponsors
Universiteit voor Wetenschap en Technologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g. Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Age > 18 years at time of study entry. 3. ECOG performance status of 0 or 1. 4. Body weight >30 kg. 5. Adequate normal organ and marrow function as defined below: • Haemoglobin >=10.0 g/dL. • Absolute neutrophil count (ANC) >=1.5 × 109 /L • Platelet count >=100 × 109/L • Serum bilirubin
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study with an investigational product during the last 30 days. 2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 3. Previous chemo- or radiotherapy for SCLC. Patients who have undergone surgery, but no adjuvant therapy are eligible. 4. Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. 5. Patients with Grade >=2 neuropathy will be evaluated on a case-by-case basis after consultation with the Chief Investigator. 6. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Chief Investigator. 7. Any concurrent chemotherapy, investigational product or biologic cancer therapy. 8. Any prior checkpoint inhibitor therapy, including durvalumab. 9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drugs. 10. Immediate need for thoracic radiotherapy or bulky disease outside the thorax, or need for such radiotherapy before completion of chemo-immunotherapy 11. Major surgical procedure within 28 days prior to the first dose of study drugs. Note: Local surgery of isolated lesions for palliative intent is acceptable. 12. History of allogenic organ transplantation. 13. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: a. Patients with vitiligo or alopecia. b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. c. Any chronic skin condition that does not require systemic therapy. d. Patients without active disease in the last 5 years may be included but only after consultation with the Chief Investigator. e. Patients with celiac disease controlled by diet alone. 14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 15. History of another primary malignancy except for: a. Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of IP and of low potential risk for recurrence. b. Localized breast or prostate cancer treated with hormonal therapy alone. c. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. d. Adequately treated carcinoma in situ without e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to compare the 1-year overall survival patients on reference therapy versus investigational therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the 2-year, 3-year, 4-year and 5-year overall survival, overall response rates, response rates in non-irradiated lesions, PFS, PFS in non-irradiated lesions, local control rates in the thorax, frequency and severity of adverse events, and health-related quality of life. | — |
Countries
Netherlands
Outcome results
None listed