Brief Summary
This is a prospective, multi-centre, single arm, phase 2, open label clinical trial of patients with untreated extensive-stage small-cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (ES-SCLC) suitable for first-line platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells. The aim of the trial is to assess safety, feasibility and describe efficacy of the addition of concurrent thoracic radiotherapy to usual treatment of chemotherapy and immunotherapya treatment that uses a person's immune system to fight cancer (durvalumab) in patients with ES-SCLC.
Intervention / Treatment
- Radiation: Thoracic Radiotherapy
- Drug: Etoposide with Carboplatin or Cisplatin
- Drug: Durvalumab
Inclusion Criteria:
- Provided written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Histologically or cytologically documented ES-ECLC
- Thoracic disease deemed suitable for radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells following initial systemic therapy
- If brain metastases present, then they are to be;
- asymptomatic without steroid therapy may be included or
- have required treatment (radiotherapy and/or surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence) and are clinically stable and patient is on a stable or reducing steroid dosethe amount of medication taken of no more than dexamethasone 4mg/day (or equivalent)
- Patients must be considered suitable to receive platinum-based chemotherapy regimen as first-line treatment for ES-SCLC
- ECOG performance-status score of 0 or 1 at registration
- Life expectancy ≥ 12 weeks at registration
- Body weight > 30 kg
- No prior exposure to immune-mediated therapy including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed cell death-1, anti-programmed cell death ligand-1, and anti-programmed cell death ligand-2 antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function as defined in the Protocol
- Female patients who;
- are willing to use adequate contraceptive measures until 90 days after the final dose of trial treatment
- are not breast feeding
- have a negative pregnancy test prior at registration if of child bearing potential or have evidence of non-child bearing potential by fulfilling the criteria as stated in the Protocol at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.