Trial Title:
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy
NCT ID:
NCT05796089
Condition:
Extensive-Stage Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Etoposide phosphate
Durvalumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Thoracic Radiotherapy
Description:
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).
Arm group label:
Treatment
Other name:
Thoracic Radiation Therapy
Intervention type:
Drug
Intervention name:
Etoposide with Carboplatin or Cisplatin
Description:
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.
Arm group label:
Treatment
Other name:
Platinum + Etoposide
Other name:
EP Chemotherapy
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
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).
Arm group label:
Treatment
Other name:
IMFINZI
Other name:
MEDI4736
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Westmead Hospital
Address:
City:
Sydney
Zip:
2145
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Harriet Gee
Email:
Principal Investigator
Facility:
Name:
Blacktown Hospital
Address:
City:
Sydney
Zip:
2148
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Eric Hau
Email:
Principal Investigator
Facility:
Name:
Liverpool Hospital
Address:
City:
Sydney
Zip:
2170
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Shalini Vinod
Email:
Principal Investigator
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
Brisbane
Zip:
4029
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Catherine Bettington
Email:
Principal Investigator
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Brisbane
Zip:
4102
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Margot Lehman
Email:
Principal Investigator
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Susan Harden
Email:
Principal Investigator
Facility:
Name:
St. Vincent's Hospital
Address:
City:
Melbourne
Zip:
3065
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Melissa Moore
Email:
Principal Investigator
Facility:
Name:
Austin Health
Address:
City:
Melbourne
Zip:
3084
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Sagun Parakh
Email:
Principal Investigator
Start date:
January 1, 2022
Completion date:
February 28, 2028
Lead sponsor:
Agency:
Trans Tasman Radiation Oncology Group
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Trans Tasman Radiation Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05796089
