EGFR, EGFR Exon 19 Deletion Mutation, EGFR Exon 20 Insertion Mutation, EGFR Exon 21 Mutation, Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer NSCLC, Non Small Cell Lung Carcinoma, NSCLC
Conditions
Keywords
Lung Cancer, Non Small Cell lung cancer, Metastatic lung cancer, EGFR Exon 20, EGFR Exon 19, EGFR Exon 21, NSCLC
Brief summary
The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations. The study includes two groups of people: * Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program. * Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program. The main question the study wants to answer is: How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people? People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025. No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.
Interventions
None listed
Sponsors
GFPC Investigation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old * Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting. * Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program. * Patient covered by the French National Health Insurance system or by an approved third-party payer * Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)
Exclusion criteria
* Patient placed under legal guardianship or subject to a protective legal measure * Patient who explicitly refuses the collection or use of their personal data for research purposes * Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Progression Free Survival (Investigator PFS) | From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | The Investigator Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let at the investigator 's discretion as per local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment. |
| Independent Panel Progression Free Survival (Independent Panel PFS) | From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | The Independent Panel Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progressionnt defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 centrally by an independent panel based on images provided by the site. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Clinical Characteristics | At Baseline visit, on a maximum period of 12 months | Baseline Clinical Characteristics as defined by baseline patient clinical characteristics (e.g. medical history, comorbidity, potential professional exposure, past history of cancer or auto-immune disease, smoking status, NSCLC or SCLC characteristics) |
| Overall Survival (OS) | Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum | OS is defined as the time from date of initiation of treatment combination initiation to date of death from any cause. Patients alive (or lost to follow up) at the time of analysis will be censored at the date they were last known to be alive. |
| Investigator Objective Response Rate (Investigator ORR) | From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the investigator using thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices. |
| Independent Panel Objective Response Rate (Independent Panel ORR) | From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the independent panel based on thorax-abdominal-pelvic and brain CT scans provided by the sites. |
| Adverse events | From the combination treatment start date up to a 2-year-period maximum | All adverse events experienced by the participants, whatever the grades of toxicity, will be collected according to CTCAE v5.0 (common terminology criteria for adverse events). |
| Treatment duration | From the combination treatment start date up to a 2-year-period maximum | Treatment duration as defined from the date of the first dose of of chemotherapy and amivantamab combination up to the date of the last dose of the combination received by the patient. |
| Reasons for discontinuation | From the combination treatment start date up to a 2-year-period maximum | Reason for discontinuation is defined by the reason for permanent discontinuation of combination treatment as recorded by the investigator (e.g. : disease progression, adverse event, lack of efficacy, patient decision, physician decision, other) |
| Site of progression after treatment combination administration | Assessed at each tumor evaluation scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum | Site of disease progression after combination therapy is defined as the anatomical site(s) of first documented disease progression occurring after initiation of the combination treatment, as assessed by the investigator according to the study specified response criteria (e.g., RECIST, disease specific criteria). The site of progression will be categorized (e.g., target lesions, non target lesions, new lesions; organ specific sites such as lung, liver, bone, CNS, lymph nodes, primary tumor, etc.). |
| Description of Post-progression type of treatments | From date of first lung cancer treatment administration for a 2-year-period maximum | Post-progression treatments received after documented disease progression will be collected and categorized. Data will include the type of therapy administered (e.g., systemic anticancer therapy, radiotherapy, surgery, supportive or palliative care). This measure describes subsequent lines of treatment and supports interpretation of survival outcomes. |
| Post-progression Progression Free Survival (ppPFS) | Assessed at each site visit scheduled as per local practice, from initiation of the first post-progression treatment until documented progression, death, end of treatment, or study completion, whichever occurs first, for a 2-year-period maximum | Post progression Progression Free Survival is defined as the time from the initiation date of the first post progression systemic anti cancer treatment to the date of the first documented disease progression (per local practice/standard criteria) or death from any cause, whichever occurs first. |
| Treatment outcomes by patients' baseline and disease characteristics | Assessed at each site visit scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum | Treatment outcomes by patients' baseline and disease characteristics defined as the comparison of : * Efficacy outcomes (PFS) * Safety outcomes (incidence and grade of adverse events under treatment) across predefined patient subgroups (e.g., age, performance status, metastatic sites, prior lines of therapy, biomarkers). |
| Investigator Central Nervous System Objective Response Rate (Investigator CNS ORR) | From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | Investigator ORR CNS is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria assessed by the investigator based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic. |
| Independent Panel Central Nervous System Objective Response Rate (Independent Panel CNS ORR) | From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | Independent Panel ORR CNS is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria assessed by the independent panel based on tumoral assessments performed by the site on patients with brain metastasis at diagnostic. |
| Investigator Central Nervous System Progression Free Survival (Investigator CNS PFS) | From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | Investigator PFS CNS is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed by the investigator based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic. |
| Independent Panel Central Nervous System Progression Free Survival (Independent Panel CNS PFS) | From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum | Independent Panel PFS CNS is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed by the independent panel based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic. |
| Central Nervous System Overall Survival (CNS OS) | Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum | OS CNS is defined as the time from date of initiation of treatment combination initiation to date of death from any cause on patients with brain metastasis at diagnostic. |
| Performance status | At Baseline visit, on a maximum period of 12 months | Performance status will be assessed at baseline using the validated scale called Eastern Cooperative Oncology Group \[ECOG\] Performance Status. The measure captures the participant's level of functional impairment and ability to carry out daily activities. Scores will be recorded as defined by the selected scale. |
| Age of the patient at Baseline | At Baseline visit, on a maximum period of 12 months | Age of participants will be recorded at baseline. Age will be collected in years. This measure characterizes the study population and supports demographic and subgroup analyses. |
| Body weight at Baseline | At Baseline visit, on a maximum period of 12 months | Body weight will be collected at baseline. Weight will be recorded in kilograms using a calibrated scale. This measure characterizes the study population and may support safety, dosing, or subgroup analyses. |
| Body mass index at Baseline | At Baseline visit, on a maximum period of 12 months | Body Mass Index (BMI) will be calculated at baseline using measured weight and height. BMI will be expressed in kg/m². This measure characterizes the study population and may support safety, or subgroup analyses. |
| Description of the number of cycles per post-progression treatments | From date of first lung cancer treatment administration for a 2-year-period maximum | The number of treatment cycles administered after documented disease progression will be collected for each participant. This measure captures the extent of post-progression therapy and supports interpretation of subsequent treatment exposure. |
| Description of the duration of each post-progression treatment | From date of the first lung cancer treatment administration for a 2-year-period maximum | The duration of each post-progression treatment will be recorded from the start date to the end date of the administered therapy. This measure characterizes the length of exposure to subsequent treatments following documented disease progression. |
Countries
France
Contacts
CONTACTProf. Laurent Greillier
CONTACTSoizic Ferlandin
PRINCIPAL_INVESTIGATORProf. Jean-Bernard Auliac
Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
PRINCIPAL_INVESTIGATORDr Thomas Pierret
Service de Pneumologie - Hôpital Louis Pradel GH Est-HCL
STUDY_CHAIRProf. Christos Chouaïd
Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
Outcome results
None listed