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

2 1 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Curie – Site Paris Paris France
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Universitario Infanta Sofía San Sebastian De Los Reyes Spain
Hospital Hm Nou Delfos Barcelona Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o. Tomaszow Mazowiecki Poland
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Ajagosoudf Pufzddlb Hlshkjgn Du Mskiiycme Marseille France
Ifbutlwa Cxpaei Dvjfmhcrdzxvtuwuh L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
30.09.2026
Poland Poland
Not yet recruiting
30.09.2026
Spain Spain
Not yet recruiting
30.09.2026

Trial locations

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.

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.

Trial ID:
2026-525382-47-00
Protocol code:
PUMA-ALI-4202
NCT ID:
NCT07465757
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Phase 3 study of ZL-1310 versus topotecan hydrochloride in patients with relapsed small cell lung cancer

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Austria Belgium Czechia Denmark France Germany +5
  • BMS-986525 Alone and with Nivolumab in Patients with Relapsed or Refractory Small Cell Lung Cancer

    Recruiting

    2 1 1 1
    Investigated Drugs:
    Italy Romania Spain