NsclcLungKG12CiNCT05273047
RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC
An observational study of Nsclc and KRAS P.G12C, run by Intergroupe Francophone de Cancerologie Thoracique at 3 sites in France.
Trial summary
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nsclc, KRAS P.G12C
- How many people
- 458 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring KRAS G12C mutation who received sotorasib as second line treatment or more as part of the French Early Access Program (ATU program).
Who may be able to join
- Patients with Stage IV NSCLC at time of initiation of treatment with sotorasib
- Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)
- Patients who received at least one dose of the treatment with sotorasib as part of the French Early Access Program (ATU program)
- Patients who were informed about the study and do not object for their data to be collected
- Age > 18 years
Who cannot join
- Patients enrolled in a sotorasib clinical trial
- Patients with a psychiatric history that hinders the comprehension of the information leaflet
- Patients under curatorship or guardianship
- Unable to obtain data collection
Trial locations and contacts
3 sites in 1 country.
France3 sites
Paris - Hôpital Cochin
Paris
Rouen - CHU
Rouen
Strasbourg - CHU
Strasbourg
About this study
Official title: Assessment and Follow-up of Patients With KRAS G12C-mutated Metastatic Non-Small Cell Lung Cancer Who Received Sotorasib as Part of the French Early Access Program (ATU)
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
Read the detailed description
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
The objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of NSCLC patients with a KRAS G12C mutation, treated with sotorasib in the framework of the cohort ATU in France.
- Conditions
- Nsclc, KRAS P.G12C
- Keywords
- sotorasib, real-world study, KRAS P.G12C, NSCLC, IFCT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world progression-free survival (rwPFS)
rwPFS will be defined as the time from the date of the first dose of treatment with sotorasib to the date of first occurrence of disease progression (defined by the treating physician) or death from any cause during the study
Measured: through study completion, an average of 1.5 year
Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib
Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status
Measured: 6 months
Overall survival (OS)
OS will be determined as the time from the date of first dose of treatment with sotorasib to the date of death due to any cause during the study
Measured: through study completion, an average of 1.5 year
Duration of treatment with sotorasib
Duration of treatment is defined as the time from the date of first dose of treatment with sotorasib to the date of discontinuation of treatment with sotorasib or death from any cause during the study
Measured: through study completion, an average of 1.5 year
Best response (complete response, partial response, stable disease, progression)
Best response will be defined as the best response recorded from the start of treatment with sotorasib until disease progression or start of further anti-cancer treatment
Measured: through study completion, an average of 1.5 year
Duration of response
Duration of response will be defined as the time from the date of the first documented response (complete or partial) to the earliest date of disease progression
Measured: through study completion, an average of 1.5 year
Duration of treatment with sotorasib beyond 1rst progression
Duration of treatment with sotorasib beyond progression will be defined as time between first occurrence of disease progression and treatment discontinuation
Measured: through study completion, an average of 1.5 year
Description of treatments received before and after sotorasib treatment
Description of treatments received before and after sotorasib treatment
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Aug 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NsclcStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Céline Mascaux, Study chair, Strasbourg - CHUFlorian Guisier, Study chair, Rouen - CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273047
- Sponsor's protocol ID
- IFCT-2102
- Acronym
- LungKG12Ci
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Follow-up of Patients With KRAS G12C-mutated Metastatic Non-Small Cell Lung Cancer Who Received Sotorasib as Part of the French Early Access Program (ATU)
- ClinicalTrials.gov ID
- NCT05273047
- Acronym / sponsor ID
- LungKG12Ci / IFCT-2102
- Conditions
- Nsclc, KRAS P.G12C
- Keywords
- sotorasib, real-world study, KRAS P.G12C, NSCLC, IFCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Mar 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.
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
Detailed description
The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.
The objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of NSCLC patients with a KRAS G12C mutation, treated with sotorasib in the framework of the cohort ATU in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring KRAS G12C mutation who received sotorasib as second line treatment or more as part of the French Early Access Program (ATU program).
Key inclusion criteria (5 listed)
- Patients with Stage IV NSCLC at time of initiation of treatment with sotorasib
- Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)
- Patients who received at least one dose of the treatment with sotorasib as part of the French Early Access Program (ATU program)
- Patients who were informed about the study and do not object for their data to be collected
- Age > 18 years
Key exclusion criteria (4 listed)
- Patients enrolled in a sotorasib clinical trial
- Patients with a psychiatric history that hinders the comprehension of the information leaflet
- Patients under curatorship or guardianship
- Unable to obtain data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world progression-free survival (rwPFS)
Time frame: through study completion, an average of 1.5 year
rwPFS will be defined as the time from the date of the first dose of treatment with sotorasib to the date of first occurrence of disease progression (defined by the treating physician) or death from any cause during the study
Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib
Time frame: 6 months
Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status
Overall survival (OS)
Time frame: through study completion, an average of 1.5 year
OS will be determined as the time from the date of first dose of treatment with sotorasib to the date of death due to any cause during the study
Duration of treatment with sotorasib
Time frame: through study completion, an average of 1.5 year
Duration of treatment is defined as the time from the date of first dose of treatment with sotorasib to the date of discontinuation of treatment with sotorasib or death from any cause during the study
Best response (complete response, partial response, stable disease, progression)
Time frame: through study completion, an average of 1.5 year
Best response will be defined as the best response recorded from the start of treatment with sotorasib until disease progression or start of further anti-cancer treatment
Duration of response
Time frame: through study completion, an average of 1.5 year
Duration of response will be defined as the time from the date of the first documented response (complete or partial) to the earliest date of disease progression
Duration of treatment with sotorasib beyond 1rst progression
Time frame: through study completion, an average of 1.5 year
Duration of treatment with sotorasib beyond progression will be defined as time between first occurrence of disease progression and treatment discontinuation
Description of treatments received before and after sotorasib treatment
Time frame: through study completion, an average of 1.5 year
Description of treatments received before and after sotorasib treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- IFCT websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Céline Mascaux study chair
Strasbourg - CHU
Florian Guisier study chair
Rouen - CHU
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nsclc and KRAS P.G12C, run by Intergroupe Francophone de Cancerologie Thoracique at 3 sites in France.
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 5 inclusion and 4 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
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?
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?
Real-world progression-free survival (rwPFS) (time frame: through study completion, an average of 1.5 year). The study lists 8 primary outcomes in all. 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 29 Sep 2023.