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

NCT ID: NCT05796089

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2028-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Thoracic Radiotherapy

Intervention Type: 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).

Etoposide with Carboplatin or Cisplatin

Intervention Type: 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.

Durvalumab

Intervention Type: 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).

Interventions

Thoracic Radiotherapy

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).

Intervention Type: RADIATION

Etoposide with Carboplatin or Cisplatin

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.

Intervention Type: DRUG

Durvalumab

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).

Intervention Type: DRUG

Other Intervention Names

Thoracic Radiation Therapy; Platinum + Etoposide; EP Chemotherapy; IMFINZI; MEDI4736

Eligibility Criteria

Inclusion Criteria

• 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;

1. asymptomatic without steroid therapy may be included or

2. 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;

1. are willing to use adequate contraceptive measures until 90 days after the final dose of trial treatment

2. are not breast feeding

3. 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

Exclusion Criteria

• Treatment with any of the following:

1. 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

2. An investigational product during the last 4 weeks

3. 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

4. Immunosuppressive medication within 14 days before the first dose of durvalumab. Some exceptions apply

5. Live, attenuated vaccine within 30 days prior to the first dose of durvalumab

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hau

Role: STUDY_CHAIR

Westmead/Blacktown Hospital

Sagun Parakh

Role: PRINCIPAL_INVESTIGATOR

Austin Health

Locations

Westmead Hospital

Sydney, New South Wales, Australia

Blacktown Hospital

Sydney, New South Wales, Australia

Liverpool Hospital

Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

St. Vincent's Hospital

Melbourne, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 40623886 (View on PubMed)

Other Identifiers

TROG 20.01 CHEST RT

Identifier Type: -

Identifier Source: org_study_id