Thoracic Radiotherapy for Extensive-stage Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Extensive-stage Small Cell Lung Cancer+1 MoreThoracic Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding immunotherapy or a PARP inhibitor to thoracic radiation therapy is safe and effective in people with ES-SCLC who have responded to first-line platinum-based chemotherapy.

Eligible Conditions
  • Extensive-stage Small Cell Lung Cancer
  • Small-cell Lung Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 12 months

13 weeks
Phase 1: Unacceptable Serious Adverse Events (SAEs)
6 months
Phase IB: Progression Free Survival
Up to 12 months
Median Progression Free Survival
Overall Survival

Trial Safety

Side Effects for

Pemetrexed, Cisplatin, and Thoracic Radiotherapy
48%Nausea
30%Dysphagia
26%Oesophagitis
24%Constipation
20%Asthenia
19%Neutropenia
16%Cough
16%Fatigue
14%Dyspnoea
13%Leukopenia
12%Vomiting
11%Radiation skin injury
11%Stomatitis
11%Radiation oesophagitis
9%Decreased appetite
9%Diarrhoea
9%Pyrexia
8%Haemoglobin decreased
8%Anaemia
8%Dysgeusia
8%Dyspepsia
8%Dizziness
7%Conjunctivitis
7%Lymphopenia
7%Vertigo
7%Back pain
7%Rash
6%White blood cell count decreased
6%Thrombocytopenia
6%Chest pain
6%Neutrophil count decreased
4%Pulmonary embolism
2%Dehydration
2%General physical health deterioration
1%Pneumonia
1%Cerebrovascular accident
1%Renal impairment
1%Urinary retention
1%Paraesthesia
1%Septic shock
1%Enteritis
1%Hypoacusis
1%Gastritis erosive
1%Device related infection
1%Hyponatraemia
1%Syncope
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01000480) in the Pemetrexed, Cisplatin, and Thoracic Radiotherapy ARM group. Side effects include: Nausea with 48%, Dysphagia with 30%, Oesophagitis with 26%, Constipation with 24%, Asthenia with 20%.

Trial Design

4 Treatment Groups

Thoracic Radiotherapy plus Durvalumab
1 of 4
Thoracic Radiotherapy plus Durvalumab and 300mg Tremelimumab
1 of 4
Thoracic Radiotherapy plus Durvalumab and 75mg Tremelimumab
1 of 4
Thoracic Radiotherapy plus Durvalumab and Olaparib
1 of 4

Active Control

Experimental Treatment

25 Total Participants · 4 Treatment Groups

Primary Treatment: Thoracic Radiotherapy · No Placebo Group · Phase 1

Thoracic Radiotherapy plus Durvalumab and 300mg TremelimumabExperimental Group · 3 Interventions: Thoracic Radiotherapy, Durvalumab, Tremelimumab · Intervention Types: Radiation, Drug, Drug
Thoracic Radiotherapy plus Durvalumab and 75mg TremelimumabExperimental Group · 3 Interventions: Thoracic Radiotherapy, Durvalumab, Tremelimumab · Intervention Types: Radiation, Drug, Drug
Thoracic Radiotherapy plus Durvalumab and OlaparibExperimental Group · 3 Interventions: Olaparib Pill, Thoracic Radiotherapy, Durvalumab · Intervention Types: Drug, Radiation, Drug
Thoracic Radiotherapy plus DurvalumabNoIntervention Group · 1 Intervention: Thoracic Radiotherapy plus Durvalumab · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracic Radiotherapy
2003
Completed Phase 2
~110
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,993 Previous Clinical Trials
247,418,555 Total Patients Enrolled
2 Trials studying Extensive-stage Small Cell Lung Cancer
177 Patients Enrolled for Extensive-stage Small Cell Lung Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
503 Previous Clinical Trials
125,964 Total Patients Enrolled
1 Trials studying Extensive-stage Small Cell Lung Cancer
21 Patients Enrolled for Extensive-stage Small Cell Lung Cancer
Alberto A Chiappori, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
57 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be willing and able to comply with the study requirements.
Participants must have small cell lung cancer, documented by histology or cytology from brushing, washing, fine needle aspiration or core biopsy from a defined lesion, but not from sputum cytology alone
You have a histological diagnosis of ES-SCLC.