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Anti-mitotic agent

Alisertib for Small Cell Lung Cancer (ALISCA-Lung1 Trial)

Phase 2
Recruiting
Research Sponsored by Puma Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed ES-SCLC
Progression on or after first-line platinum-based chemotherapy. Patients must have also received a prior anti-PDL-1 immunotherapy agent
Must not have
Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose to death, assessed up to 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how safe & effective alisertib is in treating patients with advanced small cell lung cancer after first-line treatment. They'll also look for biomarkers to identify subgroups who may benefit most.

Who is the study for?
This trial is for adults over 18 with extensive-stage small cell lung cancer (ES-SCLC) who have already tried platinum-based chemotherapy and an anti-PDL-1 immunotherapy agent but the cancer has progressed. People can't join if they've previously been treated with AURKA or pan-Aurora-targeted agents, including alisertib.
What is being tested?
The study is testing the effectiveness of a drug called Alisertib in patients whose ES-SCLC has worsened despite initial treatments. It aims to understand how safe Alisertib is, how it affects the body, and which specific patient groups might benefit most from it.
What are the potential side effects?
While not explicitly listed here, side effects of Alisertib may include typical reactions to cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of small cell lung cancer confirmed by a lab test.
Select...
My cancer progressed after first-line platinum chemotherapy and I've had anti-PDL-1 treatment.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with a drug targeting AURKA or Aurora kinases, like alisertib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose to death, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose to death, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Control Rate (DCR) within biomarker-defined subgroup
Duration of response (DOR) within biomarker-defined subgroup
Objective response rate (ORR) within biomarker-defined subgroup
+2 more
Secondary study objectives
Disease Control Rate (DCR) in the enrolled patient population
Duration of response (DOR) in the enrolled patient population
Objective response rate (ORR) in the enrolled patient population
+3 more

Side effects data

From 2017 Phase 2 trial • 178 Patients • NCT02038647
55%
Diarrhoea
47%
Neutropenia
44%
Anaemia
44%
Fatigue
34%
Nausea
33%
Decreased appetite
32%
Vomiting
31%
Stomatitis
24%
Dyspnoea
20%
Cough
17%
Dizziness
16%
Asthenia
16%
Neutrophil count decreased
16%
Alopecia
15%
Weight decreased
14%
White blood cell count decreased
14%
Abdominal pain
14%
Leukopenia
11%
Hypokalaemia
10%
Febrile neutropenia
10%
Headache
10%
Arthralgia
9%
Dyspepsia
9%
Constipation
9%
Pyrexia
9%
Neuropathy peripheral
8%
Dehydration
8%
Abdominal pain upper
8%
Thrombocytopenia
8%
Hypocalcaemia
8%
Insomnia
7%
Oedema peripheral
7%
Muscular weakness
6%
Fall
6%
Hypertension
6%
Hyperglycaemia
6%
Gastrooesophageal reflux disease
6%
Dysphagia
6%
Hypomagnesaemia
6%
Dysphonia
6%
Somnolence
6%
Back pain
5%
Non-cardiac chest pain
5%
Productive cough
5%
Paraesthesia
5%
Hypoaesthesia
5%
Musculoskeletal pain
3%
General physical health deterioration
3%
Pneumonia
3%
Respiratory failure
3%
Epistaxis
3%
Pain in extremity
2%
Upper respiratory tract infection
2%
Neutropenic sepsis
2%
Lung neoplasm malignant
2%
Pulmonary embolism
2%
Dysgeusia
2%
Confusional state
1%
Glioblastoma
1%
Pancytopenia
1%
Bacteraemia
1%
Oral herpes
1%
Sepsis
1%
Septic shock
1%
Influenza
1%
Respiratory tract infection
1%
Fungal infection
1%
Tumour pain
1%
Metastases to meninges
1%
Acute respiratory failure
1%
Acute coronary syndrome
1%
Systemic inflammatory response syndrome
1%
Seizure
1%
Pulmonary oedema
1%
Cardiac failure
1%
Diabetic metabolic decompensation
1%
Ataxia
1%
Mental status changes
1%
Aortic thrombosis
1%
Paraplegia
1%
Bile duct stenosis
1%
Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alisertib + Paclitaxel
Placebo + Paclitaxel

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AlisertibExperimental Treatment1 Intervention
50 mg of alisertib PO BID on days 1-7 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
2010
Completed Phase 2
~1260

Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Lead Sponsor
57 Previous Clinical Trials
10,069 Total Patients Enrolled
Chief Scientific OfficerStudy DirectorPuma Biotechnology, Inc.
10 Previous Clinical Trials
2,626 Total Patients Enrolled
~28 spots leftby Jul 2025
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