Lung CancerPhase 2SOLUCOMNCT05311709
Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities
A Phase 2 study testing sotorasib in people with Lung Cancer and NSCLC, Stage III, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, Stage III, NSCLC Stage IV
- What is being tested?
- sotorasib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 30 May 2022to 1 Mar 2025
- 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
- Provision of signed and dated, written informed consent.
- Age > 18 years.
- Histologically or cytologically documented NSCLC stage III/IV not amenable for curative treatment. Patients that have received systemic adjuvant therapy for non-metastatic disease in the past will need a new biopsy before inclusion if no biopsy acquired after adjuvant therapy is available.
- Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method.
- Subjects will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable for curative treatment. Prior treatment must include checkpoint inhibitor for advanced or metastatic disease, either given alone or in combination with chemotherapy unless the subject has a medical contraindication to one of the required therapies.
- Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
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- Disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy.
- ECOG status 0-2 and a minimum life expectancy of 12 weeks. At least 60 patients should be in ECOG 2. When 40 patients in ECOG 0-1 are included, the inclusion criteria will change to only ECOG 2.
- At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1. Brain metastases are not regarded measurable.
- Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Male subjects must be willing to use barrier contraception.
- Mean resting corrected QT interval (QTc) < 470 msec (females) or < 450 msec (males) using the screening clinic ECG machine derived QTc value.
- Adequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values:
- Absolute neutrophil count > 1.5 x 109/L
- Platelet count > 100 x 109/L
- Haemoglobin > 9.0 g/dL
- Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or < 5 times ULN in the presence of liver metastases
- Aspartate aminotransferase (AST) < 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
- Total bilirubin < 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
- Serum creatinine < 1.5 times ULN concurrent with creatinine clearance < 45 mL /min [measured or calculated by Cockcroft and Gault equation]-confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN
Who cannot join
- Previously identified driver mutation (according to local standard of care or guidelines) other than KRASG12C for which an approved therapy is available (including EGFR, ALK, etc).
- Symptomatic brain metastases or leptomeningeal disease. Subjects that have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to study day 1 are eligible if they meet all the following criteria: a) residual neurological symptoms grade ≤ 2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up MRI performed within 30 days prior to enrolment shows no progression or new lesions appearing.
- Major surgery within 4 weeks of inclusion
- Radiotherapy treatment within 2 weeks of inclusion. Subjects must have recovered from all radiotherapy related toxicity to CTCAE version 5.0 grade 1 or less with the exception of alopecia (any grade of alopecia allowed).
- Anti-tumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy [except for subjects with history of completely resected breast cancer with no active disease on long term adjuvant endocrine therapy], or investigational agent) within 4 weeks (chemotherapy within 2 weeks) of study day 1. Targeted small molecule inhibitors, within 14 days of study day 1, or within 5 half-lives, whichever is longer. Please note that bisphosphonates or anti RANKL antibody therapy is allowed if needed for management of hypercalcemia or for prevention of skeletal events.
- Previous treatment with sotorasib or other KRASG12C inhibitor
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- Use of warfarin. Other anticoagulation is allowed.
- Patients with significant comorbidities other than those mentioned below:
- Comorbidities of special interest (up to grade 2 according to ACE-27 scoring system (see appendix A and (20)), or toxicity CTCAE 2) are eligible (ACE-27 grade 3 or CTCAE grade 3 may be eligible after discussion with Sponsor). Patients may have more than one comorbidity as long as all are within the severity grades as mentioned. Comorbidities of special interest are the following:
- Autoimmune diseases (rheumatoid, colitis, diabetes, skin, multiple sclerosis etc), including immunotherapy-induced morbidity (colitis, pneumonitis, endocrinopathies, non-viral hepatitis, nephritis etc). Immunotherapy-induced colitis or pneumonitis must be resolved to maximum CTCAE 2, and a maximum use of prednisolone 10 mg or equivalent is allowed.
- Smoking-induced diseases (cardiovascular (coronary artery disease, apoplexia, thromboembolic events), COPD/emphysema etc). Note: Myocardial infarction within 6 months prior to enrolment, unstable arrhythmias or unstable angina are not eligible.
- The following comorbidities are ineligibility criteria: i. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Previous malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry.
- Significant gastrointestinal disorder that results in requirement for intravenous alimentation, or inability to take oral medication.
- Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator. Use of strong inducers of CYP3A4 (including herbal supplements such as St. John's wort) within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the principal investigator.
- History of hypersensitivity of active or inactive excipients of sotorasib or drugs with a similar chemical structure or class to sotorasib.
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
- Previous enrolment in the present study or previous treatment with sotorasib.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 2, unless discussed with Sponsor.
- Women who are pregnant or breast-feeding, or have a positive (urine or serum) pregnancy test prior to study entry
- Involvement in the planning and/or conduct of the study (investigator staff and/or staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Vestre Viken Health Trust
Drammen, Akershus, 3004
Siri Bråthen, MSc, +4745226100, sibraa@vestreviken.no
About this study
A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.
Read the detailed description
A single-arm multi-institutional phase II study to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.
The aim is to investigate whether treatment with sotorasib will provide significant objective response rates in predefined KRASG12C-mutated non-small cell lung cancer patients that are not typically included in phase III-studies. Furthermore, the trial will explore whether patients in performance status ECOG 2 may benefit from sotorasib. In this study, a relevant number of sotorasib-naïve patients (n=100) will be treated with sotorasib and followed for efficacy and side effects. MRI-scans both at base-line and regularly during therapy will give data on intracranial efficacy. Eligible patients will be previously treated with at least 1 line standard (chemo)immunotherapy, or deemed in-eligible for standard (chemo)immunotherapy.
In part II of the study, comprehensive analyses of biological samples taken pretreatment, and post-progression will provide novel information about resistance mechanisms on sotorasib. Furthermore, analyses of biopsies taken at partial response (estimated to be performed in 25-30% of cases) may potentially also characterize non-eradicated residual cells after achieved response. The post-progression biopsies may indicate the optimal next-line therapy.
- Conditions
- Lung Cancer, NSCLC, Stage III, NSCLC Stage IV, Lung Cancer Stage IV, Mutation, Cancer
- Being tested
- sotorasib
- Keywords
- KRAS G12C
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotorasibDrug
single group, all patients receive sotorasib
| Study group | Role | What they receive |
|---|---|---|
| Sotorasib | Experimental | Single arm trial. All patients will be included in this interventional arm. Receives: Drug: sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) of sotorasib reducing tumour size in the all subjects treated
Evalution of tumour size by RECIST v1.1 criteriae
Measured: every eigth week until progression, or up to 2 years
Secondary outcomes (13)
Objective Response Rate (ORR) of sotorasib reducing tumour size in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-)immunotherapy)
Tumour evaluation by RECIST v1.1 criteriae
Measured: from study baseline and every eigth week until progression, or or up to 2 years
Evaluation of efficacy of sotorasib in pre-defined patient groups
Progression Free Survival (PFS)
Measured: From study baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib (response) in pre-defined patient groups
Duration of Response (DoR)
Measured: from baseline, through study completion, and average of 8 months
Evaluation of efficacy and disease control of investigational medicinal product sotorasib in pre-defined patient groups
Disease Control Rate (DCR)
Measured: from baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib in pre-defined patient groups
Intracranial Disease Free Survival (iDFS)
Measured: from baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib in pre-defined patient groups
Intracranial Time To Recurrence (iTTR)
Measured: through study completion, and average of 8 months
Evaluation of efficacy of sotorasib measured by tumour shrinkage in pre-defined patient groups
Tumour shrinkage measured by RECIST v1.1 criteriae
Measured: through study completion, and average of 8 months
Evaluation of efficacy of sotorasib measured in overall survival, in pre-defined patient groups
Overall Survival (OS)
Measured: through study completion, and average of 8 months
Evaluation of efficacy, measured in time to progression, of sotorasib in pre-defined patient groups
Time on treatment post progression
Measured: through study completion, and average of 8 months
To evaluate patient-reported outcome during treatment assessed by QoL: EQ-5D-5L
EQ-5D-5L scores at each assessment and changes from baseline
Measured: Change from baseline over time to week 12
To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-LC13
QLQ-LC13 scores at each assessment and changes from baseline
Measured: Change from baseline over time to week 12
To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-C30
QLQ-C30 scores at each assessment
Measured: Change from baseline over time to week 12
to estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests
NCT CTCAE
Measured: until 28 days after last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start30 May 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Model description
- Single arm, multinational phase II trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Oslo University Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Karolinska University Hospital, University Hospital of North Norway, Haukeland University Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Odd Terje Brustugun, MD, PhD, Principal investigator, Vestre Viken Health trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311709
- Sponsor's protocol ID
- SOLUCOM
- Acronym
- SOLUCOM
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities
- ClinicalTrials.gov ID
- NCT05311709
- Acronym / sponsor ID
- SOLUCOM / SOLUCOM
- Conditions
- Lung Cancer, NSCLC, Stage III, NSCLC Stage IV, Lung Cancer Stage IV, Mutation, Cancer
- Keywords
- KRAS G12C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Oslo University Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Karolinska University Hospital, University Hospital of North Norway, Haukeland University Hospital, St. Olavs Hospital
- Study start
- 30 May 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 5 Apr 2022 (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.
A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.
Detailed description
A single-arm multi-institutional phase II study to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.
The aim is to investigate whether treatment with sotorasib will provide significant objective response rates in predefined KRASG12C-mutated non-small cell lung cancer patients that are not typically included in phase III-studies. Furthermore, the trial will explore whether patients in performance status ECOG 2 may benefit from sotorasib. In this study, a relevant number of sotorasib-naïve patients (n=100) will be treated with sotorasib and followed for efficacy and side effects. MRI-scans both at base-line and regularly during therapy will give data on intracranial efficacy. Eligible patients will be previously treated with at least 1 line standard (chemo)immunotherapy, or deemed in-eligible for standard (chemo)immunotherapy.
In part II of the study, comprehensive analyses of biological samples taken pretreatment, and post-progression will provide novel information about resistance mechanisms on sotorasib. Furthermore, analyses of biopsies taken at partial response (estimated to be performed in 25-30% of cases) may potentially also characterize non-eradicated residual cells after achieved response. The post-progression biopsies may indicate the optimal next-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, multinational phase II trial
| Arm | Type | Receives |
|---|---|---|
| Sotorasib | Experimental | Drug: sotorasibSingle arm trial. All patients will be included in this interventional arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Provision of signed and dated, written informed consent.
- Age > 18 years.
- Histologically or cytologically documented NSCLC stage III/IV not amenable for curative treatment. Patients that have received systemic adjuvant therapy for non-metastatic disease in the past will need a new biopsy before inclusion if no biopsy acquired after adjuvant therapy is available.
- Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method.
- Subjects will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable for curative treatment. Prior treatment must include checkpoint inhibitor for advanced or metastatic disease, either given alone or in combination with chemotherapy unless the subject has a medical contraindication to one of the required therapies.
Key exclusion criteria (22 listed)
- Previously identified driver mutation (according to local standard of care or guidelines) other than KRASG12C for which an approved therapy is available (including EGFR, ALK, etc).
- Symptomatic brain metastases or leptomeningeal disease. Subjects that have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to study day 1 are eligible if they meet all the following criteria: a) residual neurological symptoms grade ≤ 2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up MRI performed within 30 days prior to enrolment shows no progression or new lesions appearing.
- Major surgery within 4 weeks of inclusion
- Radiotherapy treatment within 2 weeks of inclusion. Subjects must have recovered from all radiotherapy related toxicity to CTCAE version 5.0 grade 1 or less with the exception of alopecia (any grade of alopecia allowed).
- Anti-tumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy [except for subjects with history of completely resected breast cancer with no active disease on long term adjuvant endocrine therapy], or investigational agent) within 4 weeks (chemotherapy within 2 weeks) of study day 1. Targeted small molecule inhibitors, within 14 days of study day 1, or within 5 half-lives, whichever is longer. Please note that bisphosphonates or anti RANKL antibody therapy is allowed if needed for management of hypercalcemia or for prevention of skeletal events.
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 |
|---|---|---|
| sotorasibsingle group, all patients receive sotorasib | Drug | Sotorasib |
Primary outcome
Objective Response Rate (ORR) of sotorasib reducing tumour size in the all subjects treated
Time frame: every eigth week until progression, or up to 2 years
Evalution of tumour size by RECIST v1.1 criteriae
13 secondary outcomes
Objective Response Rate (ORR) of sotorasib reducing tumour size in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-)immunotherapy)
Time frame: from study baseline and every eigth week until progression, or or up to 2 years
Evaluation of efficacy of sotorasib in pre-defined patient groups
Time frame: From study baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib (response) in pre-defined patient groups
Time frame: from baseline, through study completion, and average of 8 months
Evaluation of efficacy and disease control of investigational medicinal product sotorasib in pre-defined patient groups
Time frame: from baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib in pre-defined patient groups
Time frame: from baseline, through study completion, and average of 8 months
Evaluation of efficacy of sotorasib in pre-defined patient groups
Time frame: through study completion, and average of 8 months
Evaluation of efficacy of sotorasib measured by tumour shrinkage in pre-defined patient groups
Time frame: through study completion, and average of 8 months
Evaluation of efficacy of sotorasib measured in overall survival, in pre-defined patient groups
Time frame: through study completion, and average of 8 months
Evaluation of efficacy, measured in time to progression, of sotorasib in pre-defined patient groups
Time frame: through study completion, and average of 8 months
To evaluate patient-reported outcome during treatment assessed by QoL: EQ-5D-5L
Time frame: Change from baseline over time to week 12
To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-LC13
Time frame: Change from baseline over time to week 12
To evaluate patient-reported outcome during treatment assessed by QoL: QLQ-C30
Time frame: Change from baseline over time to week 12
to estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests
Time frame: until 28 days after last treatment dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
Odd Terje Brustugun, MD, PhD principal investigator
Vestre Viken Health trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sotorasib in people with Lung Cancer and NSCLC, Stage III, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 23 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odd Terje Brustugun, MD, PhD (+4732862464, otr@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) of sotorasib reducing tumour size in the all subjects treated (time frame: every eigth week until progression, or up to 2 years). 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 9 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.