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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 Status
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Cliniche Gavazzeni S.p.A. Bergamo Italy
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Centre Francois Baclesse Caen France
Ctoqbrcle Upxcwtpjtyznpz Scnrbnxfp Woluwe-Saint-Lambert Belgium
Cipzon Ljfd Bxekxo Lyon France
Iyejifil Cfayzm Dhlfeubsofcrrnoom L'hospitalet De Llobregat Spain
Djpcounmdkls Cvrxiaf Oqbujfjfa Poudttgshuwa I Hcgwjolylai Wroclaw Poland
Ihwhegnj Rknjbwvfg Pvq Lr Sxhkgg Doi Teerqd Darp Akpiabn Iijp Sqslos Meldola Italy
Avydqctdb Ulc Amsterdam The Netherlands
Ahhmgngzde Phnfcsxl Hyjpqwmo Dq Mfqxkjepy Marseille France
Nlnkbozj Isnlulyz Ocvksikmj Iyr Mjvhe Scvyjqnlzihimdhhzbqfmkzfczky Iyjkymbm Bqtzemwx Cracow Poland
Uahtqbykaibsxk Cuallpp Kongltaic Gdansk Poland
Hcyybdoh Vvto dtjkgxig Barcelona Spain
Hhprbmmj Uumoduihyylbnw Smkzibjcko &ewxtsa Hsvbsyz dq Hyxmtuqnijd STRASBOURG, Alsace France

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

Trial status

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