TROG 20.01 CHEST RT: Chemotherapy and Immunotherapy in Extensive Stage Small Cell Lung Cancer With Thoracic Radiotherapy
Study Details
Study Description
Brief Summary
Chemotherapy and Immunotherapy in extensive stage small cell lung cancer with thoracic radiotherapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment
|
Radiation: Radiotherapy
30Gy in 10 fractions. Radiation therapy (RT) to be given either concurrently with cycle 3 or 4 of chemotherapy or within 6 weeks of finishing chemotherapy. Fractions are expected to be delivered daily. All RT treatment should be completed within 15 days
Drug: Chemotherapy
Durvalumab:
Dose - 1500mg | To be administered by intravenous infusion with chemotherapy every 3 weeks for 4 cycles. Once the chemotherapy cycles complete, 1500mg of Durvalumab will be given every 4 weeks until disease progression (also known as maintenance therapy).
Etoposide:
Dose - as standard practice | Treatment with chemotherapy will be limited to 4 cycles on a 3 weekly schedule. It is to be prescribed and administered by intravenous infusion according to local prescribing information.
Platinum based chemotherapy (Cisplatin or Carboplatin):
Dose - as standard practice | Treatment with chemotherapy will be limited to 4 cycles on a 3 weekly schedule. It is to be prescribed and administered by intravenous infusion according to local prescribing information.
|
Outcome Measures
Primary Outcome Measures
- Safety change [At 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks, 68 weeks, 88 weeks, 104 weeks, 124 weeks, 140 weeks, 140 weeks, 156 weeks]
Safety assessed according to the Common Terminology Criteria for Adverse Events (CTCAE5) for oesophageal or pneumonitis toxicity
- Feasibility of treatment change [At 4 weeks, 8 weeks, 24 weeks, 36 weeks, 52 weeks, 68 weeks, 88 weeks, 104 weeks, 124 weeks, 140weeks and 156 weeks post completion of chemo-immunotherapy.]
Feasibility assessed by the continuation of systematic therapy is considered safe secondary to radiation toxicities (as assessed by a clinical assessment by a clinician) and the ability of the disease to be encompassed within a reasonable radiation portal and completing the full course of radiation therapy.
Secondary Outcome Measures
- Survival [Death due to any cause as time to event and proportion at one year and 2 years post intervention commencement]
Overall survival assessed at follow up visits or via medical records of death
- Progression free survival [Death or disease progression as time to event and proportion at 6 months and 1 year post-intervention commencement]
Progression free survival assessed at follow up visits or via medical records
- Patterns of failure [Patterns of failure detected at imaging at cycle 2/day 11 of chemo-immunotherapy then at 4 weeks, 8 weeks, 24 weeks, 36 weeks, 52week, 68 weeks, 88 weeks, 104 weeks, 124 weeks, 140weeks and 156 weeks post completion of chemo-immunotherapy.]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age greater than or equal to 18,
-
Untreated ES-SCLC patients
-
Provided written informed consent
-
Histologically or cytologically documented ES-SCLC - ES-SCLC defined as; American Joint Committee on Cancer [8th edition] SCLC stage IV
-
T any, N any, M1 a/b/c, or
-
T3?4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a feasible radiation plan
-
ECOG performance-status score of 0 or 1 at registration. Patients with worse performance status (PS) prior to cycle 1 may be included if PS improves to 0-1 prior to cycle 2; these patients would be registered prior to cycle 2
-
Life expectancy greater than or equal to 12 weeks at registration
-
Brain metastases must be controlled or asymptomatic
-
Thoracic disease deemed suitable for radiation therapy following initial systemic therapy
-
Bodyweight of at least 30 kg
-
Suitability for first-line platinum-based chemotherapy
-
Adequate organ and marrow function; and negative pregnancy test for pre-menopausal women
-
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.
Exclusion Criteria:
-
Previous high dose radiotherapy to the chest precluding mediastinal radiation
-
Significant active or previous autoimmune or inflammatory disorder
-
Paraneoplastic syndrome of autoimmune nature requiring systemic treatment
-
Interstitial lung disease/pulmonary fibrosis
-
History of active primary immunodeficiency
-
Uncontrolled, concurrent illness or active infections
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Westmead Hospital | Sydney | New South Wales | Australia | 2145 |
| 2 | Blacktown Hospital | Sydney | New South Wales | Australia | 2148 |
| 3 | LiverpoolHospital | Sydney | New South Wales | Australia | 2170 |
| 4 | Royal Brisbane Women's Hospital | Brisbane | Queensland | Australia | 4029 |
| 5 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | 4102 |
| 6 | Peter MacCallum Parkville | Melbourne | Victoria | Australia | 3000 |
| 7 | Austin Health | Melbourne | Victoria | Australia | 3084 |
Sponsors and Collaborators
- Trans Tasman Radiation Oncology Group
- AstraZeneca
Investigators
- Principal Investigator: Eric Hau, Westmead/Blacktown Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TROG 20.01 CHEST RT