Carboplatin for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Malignant Neoplasms+6 More
Carboplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well radiation therapy works after chemo and immunotherapy to shrink tumors in patients with stage IV small cell lung cancer.

Eligible Conditions
  • Malignant Neoplasms
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Small cell carcinoma of lung

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Up to 3 years
Healthcare related quality of life: EORTC QLQ-C30
Healthcare related quality of life: EORTC QLQ-LC13
Overall survival
Progression free survival
Response rate
Day 90
Incidence of grade 2 or higher pneumonitis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

10 MG/KG Ipilimumab + Paclitaxel/ Carbop
38%Alopecia
36%Anaemia
32%Nausea
31%Decreased appetite
31%Diarrhoea
30%Fatigue
25%Constipation
23%Neutropenia
20%Dyspnoea
19%Pyrexia
19%Vomiting
18%Rash
17%Cough
17%Asthenia
16%Arthralgia
16%Pruritus
16%Thrombocytopenia
15%Peripheral sensory neuropathy
14%Myalgia
13%Neuropathy peripheral
13%Insomnia
11%Hypokalaemia
10%Platelet count decreased
9%Pain in extremity
9%Leukopenia
9%Weight decreased
8%Hyponatraemia
8%Pneumonia
8%Alanine aminotransferase increased
8%Haemoglobin decreased
7%Back pain
7%Malignant neoplasm progression
7%Neutrophil count decreased
7%Aspartate aminotransferase increased
7%Dizziness
7%Bone pain
7%Haemoptysis
6%Hypomagnesaemia
6%Stomatitis
6%Headache
5%Abdominal pain
5%Oedema peripheral
5%Chest pain
5%Abdominal pain upper
5%White blood cell count decreased
5%Dehydration
4%Musculoskeletal pain
4%Febrile neutropenia
4%Paraesthesia
3%Colitis
2%Lung infection
2%Pulmonary embolism
2%Death
2%Mucosal inflammation
1%Cardio-respiratory arrest
1%Urinary tract infection
1%Pulmonary haemorrhage
1%Interstitial lung disease
1%Chronic obstructive pulmonary disease
1%Confusional state
1%Drug hypersensitivity
1%Cerebrovascular accident
1%Lung abscess
1%Multi-organ failure
1%Blood creatinine increased
1%Metastases to central nervous system
1%Atrial fibrillation
1%Disease progression
1%Renal failure
1%Liver function test abnormal
1%Lower respiratory tract infection
1%Lung neoplasm malignant
1%Pain
1%Acute kidney injury
1%Hypersensitivity
1%General physical health deterioration
1%Intestinal perforation
1%Pneumothorax
1%Infection
1%Pneumonitis
1%Respiratory failure
1%Syncope
1%Hyperglycaemia
1%Sudden death
1%Sepsis
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01285609) in the 10 MG/KG Ipilimumab + Paclitaxel/ Carbop ARM group. Side effects include: Alopecia with 38%, Anaemia with 36%, Nausea with 32%, Decreased appetite with 31%, Diarrhoea with 31%.

Trial Design

1 Treatment Group

Treatment (durvalumab, chemotherapy, radiation therapy)
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Carboplatin · No Placebo Group · Phase 2

Treatment (durvalumab, chemotherapy, radiation therapy)Experimental Group · 7 Interventions: Etoposide, Questionnaire Administration, Carboplatin, Cisplatin, Durvalumab, Quality-of-Life Assessment, Hypofractionated Radiation Therapy · Intervention Types: Drug, Other, Drug, Drug, Biological, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Carboplatin
FDA approved
Platinum
Not yet FDA approved
Durvalumab
FDA approved
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,956 Previous Clinical Trials
91,808,811 Total Patients Enrolled
University of WashingtonLead Sponsor
1,583 Previous Clinical Trials
1,565,936 Total Patients Enrolled
Jing ZengPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
7 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female 18 years or older.
Patients must be considered suitable to receive a platinum-based chemotherapy regimen as first-line treatment for ES-SCLC
You are able to provide written informed consent.
You must be willing to have a life expectancy of at least 12 weeks at enrollment.
You have a body weight of more than 30 kg.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.