#1 Clinical Trials Search in Europe

Comparison of Sotorasib versus Docetaxel in Previously Treated Non-Small Cell Lung Cancer Patients with KRAS p.

3 1 1 1

What is this study about?

This study focuses on patients with non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body (metastatic), and specifically has a certain genetic change called KRAS p.G12C mutation. The study compares two treatments: sotorasib (also known as AMG 510), which is taken as tablets by mouth, and docetaxel, which is given through an infusion into a vein. Patients may also receive dexamethasone, a medication that helps manage side effects.

The main goal of this research is to determine if sotorasib works better than docetaxel in treating this specific type of lung cancer. The study will measure how long the cancer can be controlled before it starts growing again and how long patients live with either treatment. During the study, doctors will also track changes in cancer-related symptoms such as breathing problems, coughing, and chest pain.

Throughout the study, patients will have regular medical check-ups and imaging tests to monitor their cancer. The research team will evaluate how well each treatment works by looking at changes in tumor size and watching for signs that the cancer is growing or spreading. They will also assess how the treatments affect patients’ daily activities and overall well-being.

1 Initial assessment

You will undergo an assessment to confirm your eligibility for the study. This includes verification that you are at least 18 years old and have non-small cell lung cancer with a specific genetic change called KRAS p.G12C mutation.

Your ability to perform daily activities will be evaluated using a scale called ECOG, which must show a score of 1 or better.

2 Random assignment to treatment group

You will be randomly assigned to receive either sotorasib tablets taken by mouth or docetaxel given through an intravenous infusion.

If assigned to the docetaxel group, you will also receive dexamethasone tablets as part of your treatment.

3 Treatment period

Your treatment will be organized in cycles, during which you will receive either sotorasib or docetaxel.

Regular assessments will be performed to monitor how your cancer responds to the treatment.

Imaging scans will be reviewed by independent specialists to evaluate any changes in your condition.

4 Health monitoring

Your symptoms will be regularly assessed, focusing on breathing difficulties, coughing, and chest pain.

Your overall physical functioning and health status will be evaluated, particularly during the first 12 weeks of treatment.

Regular medical examinations and tests will be conducted to monitor your response to treatment.

5 Study completion

The study will continue until either your disease progresses or other factors determine the end of your participation.

The overall study is expected to continue until April 2027.

Your health status will continue to be monitored even after completing the active treatment phase.

Who Can Join the Study?

  • Age: Must be 18 years or older
  • Must have a KRAS p.G12C mutation (a specific genetic change in lung cancer cells) confirmed through central testing or previous documentation from Amgen Study 20190294
  • Must have non-small cell lung cancer (NSCLC) that is:
    • Locally advanced and cannot be surgically removed (unresectable), or
    • Has spread to other parts of the body (metastatic)
  • Must have received previous treatment for lung cancer
  • Must have an ECOG score of 0 or 1 (a measure of physical ability where 0 means fully active and 1 means restricted in physically strenuous activity but able to walk and do light work)
  • Both men and women can participate

Who Cannot Join the Study?

  • History of prior treatment with any KRAS G12C inhibitor (medications targeting a specific gene mutation)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • Known active infection requiring systemic therapy (infection needing medication that affects the whole body)
  • History of other cancer within the last 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart problems, including:
    – Heart attack within the past 6 months
    – Unstable angina (chest pain)
    – Heart failure requiring treatment
  • Severe liver problems or abnormal liver function tests
  • Known allergy or sensitivity to study medications
  • Pregnant or breastfeeding women
  • Any condition that would make it unsafe to participate in the study, as determined by the study doctor
  • Current participation in other clinical trials or use of investigational drugs within 28 days before starting this study
  • Unable to swallow oral medications
  • Major surgery within 28 days before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Hopital Tenon Paris France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
POIS Sachsen GmbH Leipzig Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Netherlands Cancer Institute Amsterdam The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Cllcob Lmom Btlkkv Lyon France
Ukndhadgmpni Myyxkqb Cdfqwtd Ggbfqwlxe Groningen The Netherlands
Ibcwqpoa Chiptx Dnkfbzavgbxdwidih L'hospitalet De Llobregat Spain
Ttunuzntzd Cmvzrq Huugryzl Thessaloniki Greece
Uzoduaahyr Hvmwiqly Cwzqkff Cologne Germany
Cpzgjq Hkxngejgxyg Ee Udgzmobguycpe Dh Lomqljm Limoges France
Axrugoweiu Pohqniqn Hactpibh De Mafgdklwa Marseille France
Ehvekzu Uuiglkfnulgu Mpcfgle Cxsuvkm Rcqekrgty (upqjxwo Mch Rotterdam The Netherlands
Upjkhnpvqjvgtt Cxwkcbn Kpyuqervz Gdansk Poland
Hnxwlqfh Dv Lr Snajx Cdbq I Sugf Pud Barcelona 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 recruiting
18.05.2020
Germany Germany
Not recruiting
18.05.2020
Greece Greece
Not recruiting
18.05.2020
Italy Italy
Not recruiting
18.05.2020
Poland Poland
Not recruiting
18.05.2020
Spain Spain
Not recruiting
18.05.2020
Sweden Sweden
Not recruiting
18.05.2020
The Netherlands The Netherlands
Not recruiting
18.05.2020

Trial locations

Investigated drugs:

AMG 510 is an investigational medication designed to target specific mutations in lung cancer cells, particularly those with KRAS p.G12C mutation. It is being studied as a potential treatment for non-small cell lung cancer (NSCLC) in patients who have previously received other treatments.

Docetaxel is a chemotherapy medication commonly used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with cell division, which helps to stop or slow down the growth of cancer cells. This medication is being used as the comparison treatment in this study.

Investigated diseases:

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. It develops when cells in the lungs begin to grow uncontrollably, forming tumors that can spread to nearby tissues. The disease typically progresses gradually, affecting lung function and potentially spreading to other parts of the body. NSCLC specifically with KRAS p.G12C mutation is a distinct molecular subtype where a specific genetic change occurs in the KRAS gene. This form of lung cancer can develop from the cells lining the larger airways and can progress to advanced stages where it becomes locally advanced (spreading to nearby tissues) or metastatic (spreading to distant parts of the body).

Trial ID:
2023-508214-42-00
Protocol code:
20190009
NCT ID:
NCT04303780
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of MK-1084 plus durvalumab in patients with locally advanced unresected KRAS G12C‑mutated non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated drugs:
    France Germany Greece Italy The Netherlands Poland +1

  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain