NSCLC Stage IVPhase 2ADEPPTNCT05673187
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
A Phase 2 study testing Adagrasib in people with NSCLC Stage IV and KRAS P.G12C, run by ETOP IBCSG Partners Foundation at 18 sites in 6 countries.
Trial summary
ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, KRAS P.G12C
- What is being tested?
- Adagrasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 12 Jun 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histologically or cytologically confirmed stage IV NSCLC.
- KRASG12C-mutation by local testing (by tissue or ctDNA).
- Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).
- Life expectancy ≥12 weeks.
- Measurable disease according to RECIST v1.1.
- Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort 2).
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- Adequate haematological, renal and liver function
- Men and women of childbearing potential must agree to use use highly effective contraceptive methods.
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum beta HCG pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 7 days before the first dose of adagrasib treatment.Ability to comply with the trial protocol, in the investigator's judgment.
- Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention, including the submission of mandatory biomaterial.
Who cannot join
- Prior investigational therapy within 28 days or at least 5 half-lives before enrolment.
- Prior treatment with an agent targeting KRASG12C.
- Leptomeningeal disease or untreated brain metastases.
- Patient should be neurologically stable for at least 2 weeks before enrolment, without the need for corticosteroids, except for prednisone (or its equivalent) at a dose of ≤10 mg daily.
- For patients with definitively treated brain metastases, a time period of minimum of 2 weeks must have elapsed from the last day of radiotherapy.
- History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
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- Any of the following cardiac abnormalities:
- Unstable angina pectoris or myocardial infarction within 6 months prior to enrolment.
- Symptomatic or uncontrolled atrial fibrillation within 6 months prior to enrolment.
- Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment.
- Prolonged QTc interval >480 ms or family or medical history of congenital Long QT Syndrome.
- History of stroke or transient ischemic attack within 6 months prior to enrolment.
- Ongoing need for treatment with concomitant medication with any of the following characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors that cannot be switched to alternative treatment prior to enrolment.
- Known human immunodeficiency virus (HIV) infection.
- Acute or chronic hepatitis B or C infection.
- Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
- Judgement 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
18 sites in 6 countries.
18 sites in 6 countries
Spain8 sites
Complejo Hospitalario Universitario a Coruña
A Coruña
Alicante University Hospital
Alicante
ICO Badalona - Hospital Germans Trias i Pujol
Badalona
Hospital de Basurto
Bilbao
ICO Bellvitge -H. Duran i Reynals / H. Bellvitge
L'Hospitalet de Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital General Universitario de Valencia (University Hospital Valencia)
Valencia
Ireland3 sites
Beaumont Hospital
Dublin
University Hospital Limerick
Limerick
University Hospital Waterford
Waterford
Italy3 sites
Santa Maria della Misericordia Hospital
Perugia
Istituto Nazionale Tumori "Regina Elena"
Rome
AULSS2 Marca Trevigiana Treviso
Treviso
About this study
Official title: A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status
ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).
- Conditions
- NSCLC Stage IV, KRAS P.G12C
- Being tested
- Adagrasib
- 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.
AdagrasibDrug
Adagrasib is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Adagrasib to be administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity. Receives: Drug: Adagrasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks.
The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response as defined as the rate of patients achieving a best overall response [complete response (CR) or partial response (PR)] according to RECIST v1.1
Measured: From date of enrolment until 12 weeks post-enrolment
Secondary outcomes (14)
Durable clinical benefit
Durable clinical benefit (DCB) is defined as the rate among all enrolled patients who are alive and without disease progression who achieve CR or PR, according to RECIST v1.1, or stable disease (SD) lasting for at least 24 weeks.
Measured: From date of enrolment until at least the 24-week assessment.
Time-to-progression (TTP)
Time-to-progression (TTP) is defined as the time from the date of enrolment until the date of documented progression (according to RECIST v1.1). Censoring for patients without documented progression will occur at the date of last tumour assessment without PD. 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 20-26 months after enrolment of the first patient)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of enrolment until the date of documented progression (according to RECIST v1.1) or death, 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 20-26 months after enrolment of the first patient)
Overall survival (OS)
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 last date they are 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 last patient last visit (approximately 20-26 months after enrolment of the first patient)
Safety and tolerability
The toxicity and safety profile of the protocol treatment will be evaluated by:
- 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 and serious AEs
- Deaths
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 1
Hemoglobin [g/dl]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 2
Platelet count [G/L]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 3
White blood cell count [G/L]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 1
Blood pressure systolic [mmHg]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 2
Blood pressure diastolic [mmHG]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 3
Heart rate [beats/min]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 4
Body temperature [°C]
Measured: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Patient-reported outcomes NFLSI-17
Patient-reported symptoms and functioning will be assessed by NCCN-Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 (NFLSI-17).
Measured: From the date of screening until patient's end of treatment (approximately 20-26 months after enrolment of the first patient)
Patient-reported outcomes PRO-CTCAE®
The most commonly reported treatment-related adverse effects of adagrasib (diarrhoea and vomiting) that are not covered by the NFLSI-17 will be assessed by the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®).
Measured: From the date of screening until patient's end of treatment (approximately 20-26 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.
- First posted6 Jan 2023
- Study start12 Jun 2023
- Primary completion28 Jul 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Collaborators
- Mirati Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Jarushka Naidoo, Study chair, Beaumont RCSI Cancer Centre, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673187
- Sponsor's protocol ID
- ETOP 22-22
- Other IDs
- 2022-002736-31
- Acronym
- ADEPPT
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status
- ClinicalTrials.gov ID
- NCT05673187
- Acronym / sponsor ID
- ADEPPT / ETOP 22-22
- Conditions
- NSCLC Stage IV, KRAS P.G12C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Collaborators
- Mirati Therapeutics Inc.
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AdagrasibAdagrasib to be administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed stage IV NSCLC.
- KRASG12C-mutation by local testing (by tissue or ctDNA).
- Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).
- Life expectancy ≥12 weeks.
- Measurable disease according to RECIST v1.1.
Key exclusion criteria (18 listed)
- Prior investigational therapy within 28 days or at least 5 half-lives before enrolment.
- Prior treatment with an agent targeting KRASG12C.
- Leptomeningeal disease or untreated brain metastases.
- History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
- Any of the following cardiac abnormalities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdagrasibAdagrasib is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity. | Drug | Treatment Arm |
Primary outcome
Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks.
Time frame: From date of enrolment until 12 weeks post-enrolment
The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response as defined as the rate of patients achieving a best overall response [complete response (CR) or partial response (PR)] according to RECIST v1.1
14 secondary outcomes
Durable clinical benefit
Time frame: From date of enrolment until at least the 24-week assessment.
Time-to-progression (TTP)
Time frame: From the date of enrolment until last tumour assessment (approximately 20-26 months after enrolment of the first patient)
Progression-free survival (PFS)
Time frame: From the date of enrolment until last tumour assessment (approximately 20-26 months after enrolment of the first patient)
Overall survival (OS)
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Safety and tolerability
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 1
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 2
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Laboratory parameters and abnormalities 3
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 1
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 2
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 3
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Vital signs 4
Time frame: From the date of enrolment until last patient last visit (approximately 20-26 months after enrolment of the first patient)
Patient-reported outcomes NFLSI-17
Time frame: From the date of screening until patient's end of treatment (approximately 20-26 months after enrolment of the first patient)
Patient-reported outcomes PRO-CTCAE®
Time frame: From the date of screening until patient's end of treatment (approximately 20-26 months after enrolment of the first patient)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarushka Naidoo study chair
Beaumont RCSI Cancer Centre, Beaumont Hospital
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adagrasib in people with NSCLC Stage IV and KRAS P.G12C, run by ETOP IBCSG Partners Foundation at 18 sites in 6 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 10 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Ireland, Italy, France, Belgium and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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) per RECIST v1.1, assessed at 12 weeks. (time frame: From date of enrolment until 12 weeks post-enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.