Study of alectinib, pemetrexed, carboplatin and cisplatin in patients with resectable stage I-III non-small cell lung cancer

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What is this study about?

This clinical trial focuses on patients with Non-Small Cell Lung Cancer (NSCLC) in stages I-III that can be surgically removed. The study will test different treatment combinations, including alectinib with chemotherapy drugs such as pemetrexed, carboplatin, and cisplatin. The treatments will be selected based on specific biological markers in the patients’ cancer cells.

The study consists of two groups. In one group, patients will receive treatment after their cancer has been surgically removed. In the other group, patients will receive treatment before surgery. The medications will be given either by mouth or through an intravenous infusion. The treatment period may last up to 63 months, depending on the group.

The researchers will monitor how well the treatments work and track any side effects that may occur. They will measure how many patients have their cancer completely disappear after treatment and how long patients live without their cancer returning. The study will also look at overall survival and the safety of the treatment combinations.

1 Initial diagnosis and group assignment

You have been diagnosed with non-small cell lung cancer (NSCLC) at stage I-III that can be surgically removed

Based on your test results, you will be assigned to one of two groups: Cohort B1 (after surgery) or Cohort B2 (before surgery)

Your cancer must test positive for a specific marker called ALK fusion

2 Treatment path for Cohort B1 (post-surgery)

If assigned to Cohort B1, you will first undergo surgery to remove the cancer

After surgery, you will receive a combination of treatments:

– Alectinib capsules taken by mouth

– Chemotherapy medications (pemetrexed, carboplatin, or cisplatin) given through an IV infusion

Your doctor will monitor for side effects for 28 days after the last chemotherapy treatment

3 Treatment path for Cohort B2 (pre-surgery)

If assigned to Cohort B2, you will first receive treatment before surgery:

– Alectinib capsules taken by mouth

– Chemotherapy medications (pemetrexed, carboplatin, or cisplatin) given through an IV infusion

After completing the initial treatment, you will undergo surgery to remove the cancer

Surgery should take place within 60 days of your last pre-surgery treatment

4 Follow-up period

Regular check-ups to monitor your recovery and response to treatment

Your doctor will perform tests to check your vital signs, take blood samples, and conduct heart monitoring (ECG)

The study will continue monitoring participants until July 2033

Who Can Join the Study?

Age requirement: Adults (age 18 and older)
Both men and women can participate
Must have non-small cell lung cancer (NSCLC) that can be surgically removed, specifically the type called adenocarcinoma
Must have a confirmed ALK fusion (a specific genetic change in the cancer cells)
Must be in relatively good physical condition with an ECOG score of 0 or 1 (able to perform daily activities with little or no assistance)
For patients after surgery (Cohort B1):
- Must have had complete removal of the cancer with clear margins (no cancer cells at the edges of removed tissue)
- Must have Stage II to selected Stage IIIB cancer
For patients before surgery (Cohort B2):
- Must be considered suitable for complete surgical removal of the cancer
- Must have confirmed Stage II to Stage IIIB cancer
- Must be evaluated by both a surgeon and cancer doctor before joining the study

Who Cannot Join the Study?

Previous treatment with any ALK inhibitor (medications that target a specific protein called ALK)
History of severe allergic reactions to study medications
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart problems, including uncontrolled high blood pressure or recent heart attack
Severe liver problems or abnormal liver function tests
Active or uncontrolled infections, including hepatitis B, hepatitis C, or HIV
Other types of cancer within the past 5 years (except for appropriately treated skin cancer or cervical cancer)
Pregnant or breastfeeding women
Any condition that would make it unsafe to participate in the study or interfere with the evaluation of the study treatment
Unable to swallow oral medications
Known hypersensitivity to the components of chemotherapy drugs used in the study
Mental conditions that would prevent understanding of the study requirements
Regular use of medications that could interact with the study drugs

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Francois Baclesse	Caen	France
Wiener Gesundheitsverbund	Vienna	Austria
Cieilixdf Umbqjqrjxhcvzt Sfxmafgwb	Woluwe-Saint-Lambert	Belgium
Hhzyxegr Verd dollowdb	Barcelona	Spain
Azmk Gihgyk Ottjwqyz Mzbdisejwzqgd Nmxvwksw	Milan	Italy
Ihfomoea Rpckwgrua Pzz Le Sinvgl Dtx Tgbzmi Dzmw Akbzxmc Ivnx Sngnan	Meldola	Italy
Abswbyouc Ufm	Amsterdam	The Netherlands
Autljrwyei Pduriqzi Hizfuvbv Dx Mzebqsfoq	Marseille	France
Rmboxxhdrjkkig	Copenhagen	Denmark
Ucqzkwxvbpexgc Cevxtjg Kqmtfctpd	Gdansk	Poland
Ckciei Lruw Biwaxs	Lyon	France
Hoxgvkmi Uktvxqcdxbmqp 1m Dh Oraoazt	Madrid	Spain
Ijwknpxt Crvgbc Dmyrrviggcmguolrj	L'hospitalet De Llobregat	Spain
Iiilrabg Tqykau Bjcb Gqjsjlst Pnhek Ix	Bari	Italy
Hvsckihw Ueuqgmqirvdvcw Shyvypbwwv &rvhvbe Hzzhons dd Hkainkkjjdo	STRASBOURG, Alsace	France
Itfqupih Owalwnlxln Vfvcny	Padua	Italy
Czoxhx Hdizuahtyst Ifydabpqkbsnm Do Cnjvutzqxwv	Quimper	France
Crjcozwc Gabumixld Sbdpha	Bergamo	Italy
Wbkvomrvlshgi Crmysrw Pvcmthuyntqs I Tlwpbjordmjmvmz Idb Eyeaxea I Joxnhqz Zlwjcwmby	Poznan	Poland
Hbuyrhfh Srmkw Mpmup Dnjac Mefbkwthujui	Perugia	Italy
Dlperyrxyceb Cfebxez Opncklyiz Pttbheuznjgh I Hmnzxnqixho	Wroclaw	Poland
Cxuiyqx Pvxcjfrmkqos I Tbhhyoccwutmwli W Bahflwf	Wilkowice	Poland
Ndnpwffd Iwlasoaf Ooxxjwnbz Ike Mzene Shzppiosczvcqhotxiizlnhhupfq Iqesynuh Bifcxecb	Warsaw	Poland
Hwirrghj Ckaugt Dt Lfif	Bron	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.03.2025
Belgium	Not recruiting	15.03.2025
Denmark	Not recruiting	15.03.2025
France	Not recruiting	15.03.2025
Italy	Not recruiting	15.03.2025
Poland	Not recruiting	15.03.2025
Spain	Not recruiting	15.03.2025
The Netherlands	Not recruiting	15.03.2025

Trial locations

Investigated Drugs:

Alectinib is a targeted therapy medication used to treat certain types of non-small cell lung cancer (NSCLC). It specifically works by blocking a protein called ALK (anaplastic lymphoma kinase) that helps cancer cells grow and spread. This medication is taken orally and is designed to target cancer cells while minimizing damage to healthy cells.

Chemotherapy refers to medications that kill cancer cells or stop them from growing. It works throughout the body to destroy cancer cells. In this trial, chemotherapy is used in combination with alectinib to treat early-stage lung cancer that can be surgically removed.

Investigated Diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms large malignant cells. It develops in the outer parts of the lungs and grows more slowly than small cell lung cancer. The disease typically starts in the cells that line the airways of the lungs, gradually spreading to nearby tissues. NSCLC can be classified into different stages (I through III) based on the size of the tumor and whether it has spread to nearby structures. In resectable cases, the tumor can be surgically removed.

Trial ID:

2024-511239-91-00

Protocol code:

BO43249

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of alectinib, pemetrexed, carboplatin and cisplatin in patients with resectable stage I-III non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?