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Extensive-Stage Small-Cell Lung CancerPhase 2CHEST RTNCT05796089

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

A Phase 2 study testing Thoracic Radiotherapy, Etoposide with Carboplatin or Cisplatin and Durvalumab in people with Extensive-Stage Small-Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 8 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-Stage Small-Cell Lung Cancer
What is being tested?
Thoracic Radiotherapy, Etoposide with Carboplatin or Cisplatin and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
8 sitesAustralia
Study dates
1 Jan 2022to 28 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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 screening

Who cannot join

  • 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
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  • 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
  • History of active primary immunodeficiency
  • Patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Australia8 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • St. Vincent's Hospital

    Melbourne, Victoria, 3065

  • Austin Health

    Melbourne, Victoria, 3084

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • Blacktown Hospital

    Sydney, New South Wales, 2148

  • Liverpool Hospital

    Sydney, New South Wales, 2170

Other trials in Australia

About this study

Official title: 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

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.

Being tested
Thoracic Radiotherapy, Etoposide with Carboplatin or Cisplatin, Durvalumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic RadiotherapyRadiation

    Also called Thoracic Radiation Therapy

    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).

  • Etoposide with Carboplatin or CisplatinDrug

    Also called Platinum + Etoposide, EP Chemotherapy

    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.

  • DurvalumabDrug

    Also called IMFINZI, MEDI4736

    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).

Study groups in NCT05796089
Study groupRoleWhat they receive
TreatmentExperimentalParticipants will receive Durvalumab concurrently with chemotherapy (etoposide with carboplatin or cisplatin) for 4 cycles.
Receives: Radiation: Thoracic Radiotherapy; Drug: Etoposide with Carboplatin or Cisplatin; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (4)

  1. Overall Survival

    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.

    Measured: 12 months

  2. Progression free survival

    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.

    Measured: 6 and 12 months

  3. Patterns of failure

    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.

    Measured: 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

  4. Time to local failure and local control

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

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start1 Jan 2022
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796089
Sponsor's protocol ID
TROG 20.01 CHEST RT
Acronym
CHEST RT
Status last verified
Aug 2025
First submitted
9 Feb 2023
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40623886

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thoracic Radiotherapy, Etoposide with Carboplatin or Cisplatin and Durvalumab in people with Extensive-Stage Small-Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 8 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of chemo-immunotherapy with concurrent thoracic radiotherapy (time frame: From date of consent to 90 days after trial treatment is discontinued). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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