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Safety and Tolerability of Alisertib Sodium and Paclitaxel in Patients with Small Cell Lung Cancer (Phase 2 Study)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with Small Cell Lung Cancer, a fast‑growing type of lung cancer that spreads quickly. The treatment being tested combines two medicines: Alisertib, taken as a pill (oral means by mouth), and Paclitaxel, given through a vein (intravenous infusion means the drug is delivered directly into a blood vessel).

The purpose of the study is to see how safe the combination is and how well patients can tolerate it. Participants receive the pills for the first seven days of each 21‑day treatment period, while the infusion is given on the first and eighth days of the same period; a “cycle” refers to this repeating 21‑day schedule.

Throughout the study, doctors watch for any side effects, called adverse events, and for any serious problems that might need extra care. The overall goal is to collect information that could help decide if this drug pair might be useful for treating this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Day 1 of each 21‑day cycle
On day 1 you take alisertib tablets by mouth, 140 mg, once daily.
On the same day you receive an intravenous infusion of paclitaxel, 60 mg per square meter of body‑surface area.
Step 2
Days 2–7 of each cycle
On days 2 through 7 you continue to take alisertib tablets, 140 mg each morning, by mouth.
No additional paclitaxel is given during these days.
Step 3
Day 8 of each cycle
On day 8 you receive a second intravenous infusion of paclitaxel, 60 mg per square meter of body‑surface area.
You do not take alisertib on this day.
Step 4
Days 9–21 of each cycle
During days 9 through 21 no study medication is taken.
You may attend scheduled clinic visits for safety checks, blood tests, or other assessments as instructed.
Step 5
Start of next cycle
After day 21 the next 21‑day cycle begins, repeating steps 1 through 4.
The cycle repeats until your doctor decides to stop treatment because of disease progression, side effects, or completion of the study.

Who can join the trial?

5 criteria

You must be at least 18 years old when you sign the consent form.
You need a diagnosis of Small Cell Lung Cancer (SCLC) that has been confirmed by laboratory testing of tumor cells. The cancer must be the main type; mixed SCLC is allowed, but cancers that have changed into SCLC from another type are not eligible.
You must have already received treatment with a platinum‑based chemotherapy (a type of cancer drug that contains platinum) and an anti‑PD‑1/PD‑L1 immunotherapy (a medicine that helps the immune system attack cancer). You also need to have had progression of the disease after this treatment, and, if it was possible and appropriate in regular medical care, you should have been treated with the drug tarlatamab. You can have had up to two prior treatment plans. If your cancer came back at least 90 days after the last platinum chemotherapy (called platinum‑sensitive relapse), you should have tried a second round of platinum chemotherapy and shown disease progression, unless your doctor decided a second round was not suitable.
You must have at least one tumor that can be measured on scans and is located outside the central nervous system (CNS) (the brain and spinal cord). The measurement must follow the rules of RECIST v1.1, a standard way doctors assess tumor size.
You need to provide a recent tissue sample of your tumor that has been preserved in a method called formalin‑fixed paraffin‑embedded (FFPE). An older (archival) sample is acceptable, but if none is available you must be willing to have a new biopsy taken.

Who cannot join the trial?

3 criteria

You cannot take part if you have already been treated with a drug that specifically targets AURKA (a protein that helps cells divide) or any drug that blocks the whole Aurora family of proteins, such as alisertib, in any previous cancer therapy.
You cannot take part if you have previously received a class of chemotherapy called a taxane, which includes the drug paclitaxel, at any time before.
You cannot take part if cancer has spread to your brain or spinal cord (known as CNS metastases), unless those brain tumors are stable, have been treated, show no signs of getting worse, cause no symptoms, and you have not needed steroid medication for at least two weeks.

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Verified sites

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centre Hospitalier Departemental Vendee
La Roche sur Yon, France
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Centre Hospitalier Universitaire De Nantes
Nantes, France

Trial locations

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Investigated drugs

Alisertib
is an oral tablet taken by mouth. It is an experimental medicine that blocks a protein that helps cancer cells grow and divide. In this study patients take the tablets for the first seven days of each 21‑day treatment cycle. The researchers are looking at how safe it is and how well patients can tolerate it when it is used together with another chemotherapy drug.
Paclitaxel
is a chemotherapy drug that is given through an IV infusion. It works by stopping cancer cells from multiplying, which can shrink or control the tumor. In the trial it is given on the first and eighth day of each 21‑day cycle. The drug is being studied to see how it works when combined with alisertib.

What is already known about the treatment

Alisertib
Alisertib is taken orally as an enteric‑coated tablet, usually 140 mg taken on days 1‑7 of a treatment cycle. It is still an investigational drug and is being evaluated in clinical trials for cancer treatment. The study focuses on its use together with paclitaxel for patients with small cell lung cancer. Alisertib works by blocking a protein called Aurora A kinase that helps cancer cells divide, and it is classified as an Aurora‑kinase inhibitor.
Paclitaxel
Paclitaxel is given by intravenous infusion as a solution that is mixed with fluid before it is injected into a vein. It is an approved chemotherapy drug that has been used for many years in cancer care. In this trial it is used together with alisertib to treat small cell lung cancer, and it is also used for breast, ovarian and other cancers. Paclitaxel works by keeping cell structures called microtubules stable, which stops cancer cells from dividing, and it belongs to the taxane class of chemotherapy agents.

Investigated diseases

Small Cell Lung Cancer - Small Cell Lung Cancer is a form of lung cancer that starts in the neuroendocrine cells of the airway. It grows quickly and often spreads early to nearby lymph nodes and distant organs. The tumor usually arises in the central part of the lungs and can extend into the chest cavity. As the disease advances, cancer cells may appear in the bloodstream, bones, liver, brain, and other sites. This spread leads to new tumor sites and an increase in disease burden.