Stage III Non-small Cell Lung Cancer
Conditions
Brief summary
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
Interventions
DRUGChemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
DRUGERBITUX
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
RADIATIONRadiotherapy
66 Gy (2 Gy by fraction, 5 fractions by week)
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* non-squamous stage III non-small cell lung cancer * measurable disease (RECIST 1.1) * ECOG performance status 0-1 * normal organ and marrow function
Exclusion criteria
* prior chest radiation therapy * history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years. * Prior therapy with known specific inhibitors of the EGFR. * history of severe allergic reaction to prior therapy with monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Control Rate | 16 weeks after inclusion | percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18-month Overall Survival Rate | 18 months | Percentage of patient alive 18 months after registration |
| Progression Free Survival | 52.3 months (median duration of follow-up) | Progression-free survival is defined as time between date of inclusion and progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemoradiotherapy + Cetuximab Chemoradiotherapy
Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week) | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 2 |
| Overall Study | Did not received the treatment | 4 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Chemoradiotherapy + Cetuximab |
|---|---|
| Age, Continuous | 57.32 years |
| ECOG Performance status PS = 0 | 63 Participants |
| ECOG Performance status PS = 1 | 43 Participants |
| Histological subtype Adenocarcinoma without bronchoalveolar component | 82 Participants |
| Histological subtype Adenosquamous | 1 Participants |
| Histological subtype Neuroendocrine carcinoma | 1 Participants |
| Histological subtype Non Small Cell | 14 Participants |
| Histological subtype Non Squamous Non Small Cell | 6 Participants |
| Histological subtype Sarcomatoid | 2 Participants |
| Region of Enrollment France | 106 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 67 Participants |
| Smoker | 100 Participants |
| Stage IIIA | 53 Participants |
| Stage IIIB | 51 Participants |
| Stage IV | 2 Participants |
| Unresectability cause Anatomical | 100 Participants |
| Unresectability cause Functional | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 51 / 102 |
| other Total, other adverse events | 100 / 102 |
| serious Total, serious adverse events | 26 / 102 |
Outcome results
Primary
Disease-Control Rate
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
Time frame: 16 weeks after inclusion
Population: Eligible population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemoradiotherapy + Cetuximab | Disease-Control Rate | 89 Participants |
95% CI: [0.846, 0.964]
Secondary
18-month Overall Survival Rate
Percentage of patient alive 18 months after registration
Time frame: 18 months
Population: Eligible population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemoradiotherapy + Cetuximab | 18-month Overall Survival Rate | 42.4 percentage of participant |
Secondary
Progression Free Survival
Progression-free survival is defined as time between date of inclusion and progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 52.3 months (median duration of follow-up)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chemoradiotherapy + Cetuximab | Progression Free Survival | 14.4 Months |