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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05796089




Registration number
NCT05796089
Ethics application status
Date submitted
9/02/2023
Date registered
3/04/2023
Date last updated
7/09/2023

Titles & IDs
Public title
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy
Scientific 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
Secondary ID [1] 0 0
TROG 20.01 CHEST RT
Universal Trial Number (UTN)
Trial acronym
CHEST RT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive-Stage Small-Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Thoracic Radiotherapy
Treatment: Drugs - Etoposide with Carboplatin or Cisplatin
Treatment: Drugs - Durvalumab

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


Treatment: Other: 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).

Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of chemo-immunotherapy with concurrent thoracic radiotherapy
Timepoint [1] 0 0
From date of consent to 90 days after trial treatment is discontinued
Primary outcome [2] 0 0
Feasibility of chemo-immunotherapy with concurrent thoracic radiotherapy
Timepoint [2] 0 0
From date of consent to 90 days after trial treatment is discontinued
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Progression free survival
Timepoint [2] 0 0
6 and 12 months
Secondary outcome [3] 0 0
Patterns of failure
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Time to local failure and local control
Timepoint [4] 0 0
6 and 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [8] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2148 - Sydney
Recruitment postcode(s) [3] 0 0
2170 - Sydney
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05796089
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Hau
Address 0 0
Westmead/Blacktown Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bridget Rooney
Address 0 0
Country 0 0
Phone 0 0
+61 2 40143911
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05796089