Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-03-12
First Post:
2020-08-31
Brief Title:
PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers NSCLC With PDL1 50
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Randomized Open-label Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers NSCLC With PDL1 Expression 50
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSEE
Brief Summary:
PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression 50 of tumour cells and no EGFR mutations or ALK rearrangement
The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee
One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 50 is a reduced risk of early progression which is known to occur with pembrolizumab monotherapy and therefore a better PFS
The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee
One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 50 is a reduced risk of early progression which is known to occur with pembrolizumab monotherapy and therefore a better PFS
Detailed Description:
PERSEE is a french academic prospective randomized controlled and open-label phase 3 study This trial compares the combination of chemotherapy and pembrolizumab with pembrolizumab alone as first-line treatment for advanced NSCLC molecularly characterized by a PDL1 expression level 50 and no EGFR mutations or ALK rearrangement This is a strategy trial whose primary objective is to evaluate the superiority of the chemotherapy-pembrolizumab combination over pembrolizumab using PFS as the primary endpoint as evaluated by an independent review committee
PERSEE trial is planned to include 292 patients treated at approximately 30 GFPC-affiliated or GFPC-associated centres After the screening period patients will be randomized on a 11 basis to the Chemotherapy Immunotherapy Arm or the Immunotherapy Arm Randomization will be stratified according to tumor histology squamous versus non squamous and according to the presence or absence of brain metastases Patients enrolled in this study will receive either of the following treatment regimens
1 Chemotherapy-Immunotherapy Arm
Four induction cycles once every 3 weeks associating on the first day of each cycle
Cisplatin 75 mgm² or carboplatin area under the curve AUC 5 mgmLmin pemetrexed 500 mgm² and pembrolizumab 200 mg for non-squamous NSCLC
Carboplatin AUC 6 mgmLmin paclitaxel 200 mgm² and pembrolizumab 200 mg for squamous NSCLC
After the 4 induction cycles a maintenance therapy will be possible for patients who are responding or stable as follows
Non squamous NSCLC pembrolizumab and pemetrexed combination or either drug as monotherapy if toxicity has been identified for one of them
Squamous NSCLC pembrolizumab monotherapy
For pembrolizumab treatment may be continued for a maximum of 35 cycles or until disease progression death unacceptable toxicity or following the Investigators or the patients decision to stop
For pemetrexed treatment may be continued until disease progression death unacceptable toxicity or following the Investigators or the patients decision to stop
2 Immunotherapy Arm
Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression death unacceptable toxicity or the Investigators or the patients decision to stop
Evaluations will be performed every 6 weeks 7 days during the first 4 cycles in both treatment arms then every 9 weeks 7 days for the first 12 months since D1 of cycle 1 and every 12 weeks 7 days thereafter
Evaluations will include tumor assessment according to RECIST v11 survival status concomitant medications and AE recording QoLPRO questionnaires will be performed at each cycle for the first 5 cycles in both treatment arms then every 9 weeks 7 days for the first 12 months since D1 of cycle 1 and every 12 weeks 7 days thereafter
The length of the inclusion period is 36 months 3 years The total study duration per patient will be a maximum of two years for the last patients included and a maximum of five years for the first patients included ie End-of-study Time Point for surviving patients
The total study duration includes the following
Screening Period up to 28 days
Treatment Period up to 60 months
Post-study Follow up Period until death or lost to follow-up
PERSEE trial is planned to include 292 patients treated at approximately 30 GFPC-affiliated or GFPC-associated centres After the screening period patients will be randomized on a 11 basis to the Chemotherapy Immunotherapy Arm or the Immunotherapy Arm Randomization will be stratified according to tumor histology squamous versus non squamous and according to the presence or absence of brain metastases Patients enrolled in this study will receive either of the following treatment regimens
1 Chemotherapy-Immunotherapy Arm
Four induction cycles once every 3 weeks associating on the first day of each cycle
Cisplatin 75 mgm² or carboplatin area under the curve AUC 5 mgmLmin pemetrexed 500 mgm² and pembrolizumab 200 mg for non-squamous NSCLC
Carboplatin AUC 6 mgmLmin paclitaxel 200 mgm² and pembrolizumab 200 mg for squamous NSCLC
After the 4 induction cycles a maintenance therapy will be possible for patients who are responding or stable as follows
Non squamous NSCLC pembrolizumab and pemetrexed combination or either drug as monotherapy if toxicity has been identified for one of them
Squamous NSCLC pembrolizumab monotherapy
For pembrolizumab treatment may be continued for a maximum of 35 cycles or until disease progression death unacceptable toxicity or following the Investigators or the patients decision to stop
For pemetrexed treatment may be continued until disease progression death unacceptable toxicity or following the Investigators or the patients decision to stop
2 Immunotherapy Arm
Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression death unacceptable toxicity or the Investigators or the patients decision to stop
Evaluations will be performed every 6 weeks 7 days during the first 4 cycles in both treatment arms then every 9 weeks 7 days for the first 12 months since D1 of cycle 1 and every 12 weeks 7 days thereafter
Evaluations will include tumor assessment according to RECIST v11 survival status concomitant medications and AE recording QoLPRO questionnaires will be performed at each cycle for the first 5 cycles in both treatment arms then every 9 weeks 7 days for the first 12 months since D1 of cycle 1 and every 12 weeks 7 days thereafter
The length of the inclusion period is 36 months 3 years The total study duration per patient will be a maximum of two years for the last patients included and a maximum of five years for the first patients included ie End-of-study Time Point for surviving patients
The total study duration includes the following
Screening Period up to 28 days
Treatment Period up to 60 months
Post-study Follow up Period until death or lost to follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GFPC 01-2020 | OTHER | Groupe Français de Pneumo-Cancérologie | None |