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

NCT05796089 | Active Not Recruiting Phase 2

• 1 other identifier: TROG 20.01 CHEST RT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Extensive-Stage Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Safety of chemo-immunotherapy with concurrent thoracic radiotherapy

  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.

  From date of consent to 90 days after trial treatment is discontinued

• Feasibility of chemo-immunotherapy with concurrent thoracic radiotherapy

  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.

  From date of consent to 90 days after trial treatment is discontinued

Secondary Outcomes (4)

• Overall Survival

  12 months

• Progression free survival

  6 and 12 months

• Patterns of failure

  From date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 152 weeks

• Time to local failure and local control

  6 and 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Radiation: Thoracic Radiotherapy; Drug: Etoposide with Carboplatin or Cisplatin; Drug: Durvalumab

Interventions

Thoracic Radiotherapy RADIATION

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).

Also known as: Thoracic Radiation Therapy

Treatment

Etoposide with Carboplatin or Cisplatin DRUG

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.

Also known as: Platinum + Etoposide, EP Chemotherapy

Treatment

Durvalumab DRUG

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).

Also known as: IMFINZI, MEDI4736

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent
• Histologically or cytologically documented ES-ECLC
• Thoracic disease deemed suitable for radiation therapy 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 surgery) and are clinically stable and patient is on a stable or reducing steroid dose 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

You may not qualify if:

• Treatment with any of the following:
• Concurrent chemotherapy (not relevant to patients registered prior to cycle 2 who will have received a cycle of platinum/etoposide chemotherapy), investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
• An investigational product during the last 4 weeks
• High dose radiotherapy to the chest prior to systemic therapy precluding further thoracic radiation therapy. Radiation therapy outside of the chest for palliative care (i.e., bone metastasis) is allowed but must be completed before first dose of the trial medication
• Immunosuppressive medication within 14 days before the first dose of durvalumab. Some exceptions apply
• Live, attenuated vaccine within 30 days prior to the first dose of durvalumab
• Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Durvalumab. Surgical procedures to obtain a lung cancer diagnosis or for palliation are allowed
• Medical contraindication to, known allergy or hypersensitivity to durvalumab, etoposide, carboplatin (patients with allergy/hypersensitivity to carboplatin may receive cisplatin), cisplatin, or any of their excipients
• History of allogeneic organ transplantation
• Has a para-neoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS. Patients with hyponatraemia considered due to SIADH syndrome are eligible
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis. Some exceptions apply
• Interstitial lung disease/pulmonary fibrosis. Patients with emphysema and associated limited areas of pulmonary fibrosis are eligible
• Uncontrolled intercurrent illness
• History of another primary malignancy. Some exceptions apply
• History of leptomeningeal carcinomatosis

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• AstraZeneca: collaborator

Study Sites (8)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Blacktown Hospital

Sydney, New South Wales, 2148, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

• Parakh S, Gee H, Lim A, Vinod S, Wheeler C, Rooney B, Montgomery R, Harden S, Moore M, Lehman M, Bettington C, Moodie T, Barber J, Schmidt L, Dizon J, Leigh L, Oldmeadow C, Mitchell P, Hau E. Platinum and etoposide chemotherapy, durvalumab with thoracic radiotherapy in the first-line treatment of patients with extensive-stage small-cell lung cancer: CHEST-RT (TROG 20.01) Trial - protocol for a phase II study. BMJ Open. 2025 Jul 7;15(7):e101571. doi: 10.1136/bmjopen-2025-101571.

  PMID: 40623886 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Etoposide; Carboplatin; Cisplatin; Platinum; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Eric Hau

  Westmead/Blacktown Hospital

  STUDY CHAIR

• Sagun Parakh

  Austin Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: April 3, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

AU (8)