Nsclc Clinical Trial
— LungKG12CiOfficial 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)
Verified date | September 2023 |
Source | Intergroupe Francophone de Cancerologie Thoracique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 458 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Paris - Hôpital Cochin | Paris | |
France | Rouen - CHU | Rouen | |
France | Strasbourg - CHU | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Intergroupe Francophone de Cancerologie Thoracique | Amgen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | 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 | 6 months | |
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | 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 | through study completion, an average of 1.5 year | |
Primary | Description of treatments received before and after sotorasib treatment | Description of treatments received before and after sotorasib treatment | through study completion, an average of 1.5 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05821933 -
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03269162 -
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
|
Phase 3 | |
Recruiting |
NCT05002270 -
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
|
Phase 1/Phase 2 | |
Recruiting |
NCT06315686 -
The Dynamic Monitoring of Cerebrospinal Fluid ctDNA
|
Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Recruiting |
NCT05466149 -
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
|
Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT03609918 -
Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
|
||
Recruiting |
NCT06043817 -
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
|
Phase 1/Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05078931 -
A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients
|
Phase 2 | |
Not yet recruiting |
NCT05547737 -
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
|
||
Not yet recruiting |
NCT05909137 -
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
|
||
Withdrawn |
NCT05959473 -
EGFR_IUO 3.20 Clinical Study Protocol
|
N/A | |
Not yet recruiting |
NCT05005468 -
A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.
|
Phase 2 | |
Recruiting |
NCT01690390 -
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
|
Phase 2 | |
Completed |
NCT01852578 -
Cabazitaxel in Relapsed and Metastatic NSCLC
|
Phase 2 | |
Active, not recruiting |
NCT01460472 -
Immunotherapy With Racotumomab in Advanced Lung Cancer
|
Phase 3 | |
Completed |
NCT00702975 -
Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
|
Phase 2 | |
Completed |
NCT00866970 -
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
|
Phase 2 |