Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Cisplatin

Immunomodulating Agents

Durvalumab

Etoposide phosphate

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Participants will receive Durvalumab concurrently with chemotherapy (etoposide with carboplatin or cisplatin) for 4 cycles.

Participants will receive thoracic radiotherapy to a dose of 30 Gray (Gy) in 10 fractions (3 Gy per day) concurrently with cycle 3 or 4 of chemo-immunotherapy (Group 1).

Participants who are unsuitable for concurrent radiotherapy may receive consolidation radiotherapy. Consolidation thoracic radiotherapy will be administered to a dose of 30 Gy in 10 fractions, following 4 cycles of chemo-immunotherapy (Group 2).

Treatment fractions will be delivered daily, where treatment should be completed within 15 days (9-10 fractions a fortnight).

Thoracic Radiotherapy

The chemotherapy in this study is a standard treatment for extensive-stage small-cell lung cancer (EC-SCLC). The combination of chemotherapy (etoposide + carboplatin or etoposide + cisplatin) which the participant will receive is dependent on what is standard at the treatment centre.

Chemotherapy will be administered via an intravenous infusion every 3 weeks (21 days) for 4 cycles.

Etoposide with Carboplatin or Cisplatin

The immunotherapy in this study is a standard treatment for ES-SCLC.

Participants will receive a dose of 1500 mg of Durvalumab via an intravenous infusion every 3 weeks (21 days) for 4 cycles, concurrently with chemotherapy.

A 1500 mg maintenance dose of Durvalumab will administered every 4 weeks after completion of chemotherapy (monotherapy).

Bridget Rooney

Eric Hau

Harriet Gee

Shalini Vinod

Catherine Bettington

Margot Lehman

Susan Harden

Melissa Moore

Sagun Parakh

This is a prospective, multi-centre, single arm, phase 2, open label clinical trial of patients with untreated extensive-stage small-cell lung cancer (ES-SCLC) suitable for first-line platinum-based chemotherapy. 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 immunotherapy (durvalumab) in patients with ES-SCLC.

Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy

A Phase II Study of Platinum and Etoposide Chemotherapy, Durvalumab With Thoracic Radiotherapy in the First Line Treatment of Patients With Extensive-stage Small-cell Lung Cancer

Group 1 and Group 2 will be compared for the presence of toxicity, whereby the proportion of grade 3 or higher pneumonitis and grade 3 or higher oesophagitis will be monitored using the NCI Common Terminology Criteria for Adverse Events v5.

Group 1 and Group 2 will be compared for the proportion of participants which received concurrent radiotherapy vs the proportion of participants which did not receive concurrent radiotherapy.

The two groups will also be assessed by the proportion of participants in which discontinued thoracic radiotherapy.

Overall survival will be defined as the time from the Cycle 1 day 1 of chemotherapy until the date of death by any cause. Participants who are alive by the analysis time point will be censored at the trial close out date.

Progression free survival will be defined as the time from Cycle 1 Day 1 of chemotherapy until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. Participants who are alive or have not progressed by the analysis time point will be censored at the latest of the dates contributing to a particular overall visit assessment.

Patterns of failure assessed by the proportion of patients with first site of failure in: Thoracic, Extra-thoracic or cranial sites, seen on imaging (CT/MRI) and assessed by iRECIST and/or RANO-BM criteria. The first site of treatment relapse will be collected and categorised as thoracic, extra-thoracic or cranial.

Time to thoracic local failure and proportion of participants with thoracic local control.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy	NCT05796089	Extensive-Stage...	Thoracic Radiot... Etoposide with ... Durvalumab	18 Years -	Trans Tasman Radiation Oncology Group
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy	NCT05796089	Extensive-Stage...	Thoracic Radiot... Etoposide with ... Durvalumab	18 Years -	Trans Tasman Radiation Oncology Group

Spots Global Cancer Trial Database for etoposide with carboplatin or cisplatin