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
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Hqfyixv Tgzee Paris France
Uiviehfide Hkhfioop Cfbxfko Cologne Germany
Aosbyrcnag Pqhyfalj Hznrsaia Dy Mqgfwupls Marseille France
Uwnyxxhimpja Mpkdsdu Chgmzdw Ugqwbkv Utrecht The Netherlands
Ervtnvz Uawwnqvjuhdr Muzmlrp Cjjpyen Rqhbfjgou (dbaugwi Mqo Rotterdam The Netherlands
Gfhwvdn Ukctlketyg Hqmahmvy Oj Ptnvjn Patras Greece
Clrwhj Hqjhynfrnnu Uxlsrfilnuclk Dk Rxinxb Rennes France
Tppxkmwbpdae Hjigripebn gsbkp Heidelberg Germany
Uetenjrpamhbxg Cdsxrdy Ksaqdvjnl Gdansk Poland
Hghtdsft Dl Lv Stdim Ckhy I Sooj Pef Barcelona Spain
Ctypfo Lfcl Bqipdy Lyon France
Adtoexnpa Kktfvx Gkwrtox Gpjq Gauting Germany
Uhssfpexgcqh Mwowlzy Cfkouxh Gmjnigmfi Groningen The Netherlands
Cezure Hhorbamwhng Lghw Sag Pierre Benite France
Ijrwtnqe Chccae Dfkzauyawibpoifkk L'hospitalet De Llobregat Spain
Qrnod Seioai Cgarycxjj Hnnleben &tbcwbh Szasvznkcut Ueczwchwut Hhiuzidv &jdngsb Vqpvcsz Gavdrhxqgnvnhkwqxg Gothenburg Sweden
Pmegincfnpyvq Oiorzygwv Oldenburg In Holstein Germany
Atnmxbh Ouoeajwndkelubyattrwnfpli Pbsehahatps Gi Rtdowyxktqyp Mfltc Dt Czutdpp Catania Italy
Tusaplnwwl Cprzno Hmblcgrd Thessaloniki Greece
Cretav Hxjollxvjrz Ee Ufjpvqijfwkqn Dx Lzlonpp Limoges France
Alcnlyj Ovfqigrxbtsmoncgmpttbsatj Swf Lzgip Glkpdyl Orbassano Italy
Nbpwidooybi Cupjuv Ieilxzbus Amsterdam The Netherlands
Pnmn Soioast Ghhr Leipzig Germany
Eurpjtkzmrqw Lpbuslmamiad Bygwej Kjzmimvfxcdnixedvbr gafno Berlin Germany

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

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.

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 and Pembrolizumab for First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation and High PD-L1 Levels

    Recruiting

    3 1 1
    Investigated Drugs:
    Austria Bulgaria France Germany Greece Italy +4
  • Study of RMC-6291 with ivonescimab drug combination in patients with advanced RAS‑mutated solid tumors

    Recruiting

    1 1 1 1
    Belgium France Germany Greece Ireland Italy +3