Olaparib for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small Cell Lung CancerOlaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying if olaparib and temozolomide may work better in treating patients with small cell lung cancer.

Eligible Conditions
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 2 Years

2 Years
MTD of Olaparib and Temozolomide
Methylation promoter methylation status
Overall Response Rate for Olaparib and Temozolomide
Overall Survival
PAR levels
Progression Free Survival
Safety, assessed using CTCAE version 4.0 criteria

Trial Safety

Safety Progress

1 of 3

Side Effects for

sBRCAm
51%Nausea
40%Fatigue
35%Anaemia
25%Vomiting
22%Abdominal pain
20%Asthenia
16%Diarrhoea
15%Constipation
15%Dyspepsia
13%Decreased appetite
11%Oedema peripheral
11%Urinary tract infection
11%Thrombocytopenia
11%Upper respiratory tract infection
11%Arthralgia
9%Musculoskeletal pain
9%Cough
7%Alopecia
7%Back pain
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Anxiety
5%Respiratory tract infection
5%Nasopharyngitis
5%Headache
5%Depression
5%Blood creatinine increased
5%Rash
5%Glomerular filtration rate decreased
5%Mucosal inflammation
5%Vitamin d deficiency
5%Dysgeusia
5%Pruritus
5%Hypertension
4%Neutrophil count decreased
4%White blood cell count decreased
4%Pain in extremity
4%Leukopenia
4%Dizziness
4%Abdominal distension
4%Influenza like illness
4%Hypomagnesaemia
4%Pyrexia
4%Peripheral swelling
2%Platelet count decreased
2%Muscle spasms
2%Biliary colic
2%Atrial fibrillation
2%Cardiac failure
2%Deep vein thrombosis
2%Small intestinal obstruction
2%Metastases to central nervous system
2%Bronchitis
2%Alanine aminotransferase increased
2%Myalgia
2%Oropharyngeal pain
2%Dysarthria
2%Contrast media allergy
2%Femoral neck fracture
2%Colonic abscess
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the sBRCAm ARM group. Side effects include: Nausea with 51%, Fatigue with 40%, Anaemia with 35%, Vomiting with 25%, Abdominal pain with 22%.

Trial Design

1 Treatment Group

Olaparib and Temozolomide
1 of 1

Experimental Treatment

66 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 1 & 2

Olaparib and TemozolomideExperimental Group · 2 Interventions: Olaparib, Temozolomide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,142 Total Patients Enrolled
AstraZenecaIndustry Sponsor
3,994 Previous Clinical Trials
247,422,511 Total Patients Enrolled
Zofia PiotrowskaLead Sponsor
Anna Farago, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The participant must be at least 18 years old.
The participant must have small cell lung cancer confirmed by histology or cytology, and may not be a candidate for potentially curative therapy.
At least one mass lesion that is at least 10 mm in diameter on a CT scan or MRI, which can be accurately measured and followed over time.
A patient with small cell lung cancer must have progressed radiographically following a platinum-based standard prior chemotherapy regimen
The person has a hemoglobin level of 10 or higher.
Absolute neutrophil count is a measure of the number of neutrophils in your blood
The platelet count is greater than or equal to 100 x 10^9 per liter.
Bilirubin levels that are lower than 1.5 times the upper limit of normal for a specific institution are considered normal.
If the AST (SGOT) or ALT (SGPT) levels are lower than 2.5 times the institutional upper limit of normal, then it is considered to be within the normal range
Patients must have histologically or cytologically confirmed advanced stage tumors that are not amenable to surgical resection or radiation therapy