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Metastatic Non Small Cell Lung CancerPhase 2AMBERNCT06068153

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

A Phase 2 study testing Sotorasib and Lenvatinib in people with Metastatic Non Small Cell Lung Cancer and KRAS G12C, run by ETOP IBCSG Partners Foundation at 15 sites in 4 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

AMBER is a multicentre, single-arm phase II trial. The protocol treatment consists of of sotorasib plus lenvatinib, as a second-line treatment. The primary objective of the trial is to evaluate the clinical efficacy of sotorasib plus lenvatinib, in terms of objective response rate, for patients with KRASG12C-mutant… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotorasib and Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
15 sitesin 4 countries
Study dates
Mar 2025to 30 Dec 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically documented metastatic NSCLC.
  • Documented disease progression on prior treatment. Prior treatment must have included platinum-based doublet chemotherapy and immune-checkpoint inhibition.
  • KRASG12C-mutation (identified through local molecular testing, using a validated test).
  • Measurable disease per RECIST v1.1 criteria.
  • Age ≥18 years.
  • ECOG Performance Status of 0-1.
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  • Life expectancy of >3 months.
  • Ability to swallow oral medications and willing to complete a treatment diary.
  • Adequate haematological function.
  • Adequate renal function.
  • Adequate liver function.
  • Men and women of childbearing potential must use highly effective contraception.
  • Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment.
  • Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

Who cannot join

  • Active brain metastases E.g., untreated brain lesions (new or progressing) and/or symptomatic brain lesions (symptoms as determined by the investigator).
  • Patients who have had brain metastases resected or have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to enrolment are eligible if they meet all of the following criteria:
  • Residual neurological symptoms are only of grade ≤2
  • On stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable.
  • History or presence of haematological malignancies. Exception: curatively treated haematological malignancies with no disease evidence in the last 2 years.
  • History of (non-infectious) pneumonitis that required steroids or evidence of ILD/pneumonitis.
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  • Active hepatitis B and C and uncontrolled HIV.
  • Uncontrolled blood pressure (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) in spite of an optimised regimen of antihypertensive medication.
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, long QT syndrome (LQTS), unstable angina, myocardial infarction or stroke within 6 months before enrolment, or cardiac arrhythmia requiring medical treatment at screening
  • Bleeding or thrombotic disorders or patients at risk for severe haemorrhage. The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
  • Current or recent (within 10 days of enrolment) use of aspirin (>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, or clostazol.
  • Electrolyte abnormalities that have not been corrected.
  • Proteinuria on urine dipstick testing >1+, unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <2 g/24 hours.
  • History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to inclusion.
  • Unresolved toxicities from previous lines of anti-cancer treatment regimens and/or (with the exception of alopecia) complications from major surgery prior to enrolment.
  • Previous treatment with KRAS- and/or VEGF/R inhibitors.
  • Hypersensitivity to sotorasib or lenvatinib.
  • Women who are pregnant or breastfeeding or who are planning to become pregnant or breastfeed.
  • Sexually active men and women of childbearing potential who are not willing to use a highly effective contraceptive method during the trial and for 7 days after the last dose of sotorasib and until 30 days after the last dose of lenvatinib.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

Spain8 sites

  • Alicante University Dr Balmis Hospital ISABIAL

    Alicante

  • Ico Badalona - Hospital Germans Trias I Pujol

    Badalona

  • Hospital Universitario Lucus Augusti

    Lugo

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife

  • Hospital Universitario Virgen Del Rocio

    Seville

  • Hospital Universitario de Toledo

    Toledo

  • Hospital Universitario Y Politécnico La Fe

    Valencia

Other trials in Spain

Switzerland5 sites

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona

  • Kantonsspital Graubünden

    Chur

  • HFR Fribourg

    Fribourg

  • HUG

    Geneva

  • Kantonsspital Winterthur

    Winterthur

Other trials in Switzerland

Austria1 site

  • Medical University of Innsbruck / UK für Innere Medizin V

    Innsbruck

Other trials in Austria

Germany1 site

  • University Hospital of Munich (LMU), Department of Medicine V (Pneumology/Thoracic Oncology)

    Munich

Other trials in Germany

About this study

Official title: A Multicentre, Single-arm Phase II Trial of Sotorasib Plus Lenvatinib, As Second-line Treatment in Patients with KRASG12C-mutant, Metastatic NSCLC

AMBER is a multicentre, single-arm phase II trial. The protocol treatment consists of of sotorasib plus lenvatinib, as a second-line treatment. The primary objective of the trial is to evaluate the clinical efficacy of sotorasib plus lenvatinib, in terms of objective response rate, for patients with KRASG12C-mutant, metastatic NSCLC.

Being tested
Sotorasib, Lenvatinib
Keywords
Metastatic NSCLC, KRAS G12C, Sotorasib, Lenvatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotorasibDrug

    Sotorasib is administered at a dose of 960 mg (8x 120 mg) orally, once daily until progression or unacceptable toxicity.

  • LenvatinibDrug

    Lenvatinib is administered at a dose of 20 mg orally (2x 10 mg), once daily until progression or unacceptable toxicity.

Study groups in NCT06068153
Study groupRoleWhat they receive
Treatment ArmExperimentalSotorasib + Lenvatinib
Receives: Drug: Sotorasib; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the rate of patients, among all enrolled patients, achieving a best overall response [complete response (CR) or partial response (PR)] according to RECIST v1.1, investigator assessed, by 18 weeks post-enrolment.

    Measured: From date of enrolment until 18 weeks post-enrolment.

Secondary outcomes (5)

  1. Progression-free survival per RECIST v1.1

    PFS is defined as the time from the date of enrolment until the date of documented progression (according to RECIST v1.1) or death from any cause, if progression is not documented. Censoring (for patients without progression or death) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of enrolment plus 1 day.

    Measured: From the date of enrolment until last tumour assessment (approximately 22 months after the enrolment of the first patient)

  2. Disease control rate per RECIST v1.1

    DCR is defined as the rate of patients, among all enrolled patients, that achieve CR or PR or disease stabilisation (according to RECIST v1.1, investigator assessed) at 18 weeks.

    Measured: From date of enrolment until 18 weeks post-enrolment.

  3. Overall survival

    OS is defined as the time from the date of enrolment until the date of death from any cause. Censoring (for patients who are not reported as dead) will occur at the date last known to be alive. Data for patients who do not have post-baseline information will be censored at the date of enrolment plus 1 day.

    Measured: From the date of enrolment until death from any cause (up to 22 months after the enrolment of the first patient)

  4. Duration of response

    DoR is defined as the interval from the date of first documentation of objective response (CR or PR, according to RECIST v1.1) to the date of first documented progression/relapse or death from any cause.

    Measured: From the date of enrolment until last tumour assessment or death from any cause (approximately 22 months after the enrolment of the first patient)

  5. Adverse events according to CTCAE v5.0

    All safety parameters will be summarised in tables in order to evaluate the toxicity and safety profile of the protocol treatment based on:

    • Adverse events (AEs) according to CTCAE v5.0 (any-cause as well as treatment-related) including AEs leading to dose delays and/or interruptions, withdrawal of protocol treatment, and death
    • Severe, serious, and selected AEs
    • Deaths
    • Clinically significant laboratory parameters and abnormalities, and vital signs.

    Measured: [Time Frame: From the date of enrolment until last patient last visit (approximately 22 months after enrolment of the first patient)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2023
  2. Study startMar 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Why it stopped: In view of the recent developments in the field (the increasing number of trials with new KRAS inhibitors), the window of opportunity to answer the question raised in the AMBER trial was missed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068153
Sponsor's protocol ID
ETOP 24-22
Acronym
AMBER
Status last verified
Nov 2024
First submitted
28 Sep 2023
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotorasib and Lenvatinib in people with Metastatic Non Small Cell Lung Cancer and KRAS G12C, run by ETOP IBCSG Partners Foundation at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, Switzerland, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: From date of enrolment until 18 weeks post-enrolment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06068153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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