Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602533
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2020-10-20
Brief Title:
Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer DOLPHIN
Sponsor:
Michael Hopp
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
A Phase II Randomized Study to Evaluate the Efficacy and Safety of Cisplatin or Carboplatin Etoposide and Concomitant Radiotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab Versus Cisplatin or Carboplatin Etoposide and Concomitant Radiotherapy in Patients With Limited Disease Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-06
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:
None
Brief Summary:
Combination of concomitant Radio-Chemotherapy showed a significant improvement Takada of OS and PFS in limited disease SCLC patients This clinical trial is a prospective multicenter randomized open-label parallel group phase II investigator initiated trial ITT to evaluate the efficacy and safety of Durvalumab in combination with CisplatinEtoposideRadiotherapy in patients with limited disease small-cell lung cancer SCLC
Detailed Description:
The trial is subdivided in a safety run-in phase and a randomized part with the induction phase Radiochemotherapy Durvalumab and including prophylactic cranial irradiation PCI if clinically indicated and according to local standard followed by the maintenance phase The trial starts with the safety run-in phase of 6 patients in Durvalumab group After the completion of the first cycle of all 6 patients a safety interim analysis will be performed Study should be discontinued if 2 out of 6 patients within safety run-in phase first cycle
show more than 2 AEs CTCAE grade 3 related to study drug Durvalumab
or develop pneumonitis CTCAE grade 2
or drop out Otherwise the trial can continue with randomization Eligible patients will be randomized to Durvalumab group or standard of care group 21
The safety interim analysis was performed in Q4 2021 The independent DMC has recommended the continuation of the trial
Induction phase
Durvalumab group Cisplatin 75 mgm² BSA D1 or alternatively Carboplatin AUC 5 D1 and Etoposide 100 mgm² BSA D1-3 once every 3 weeks for 4-6 cycles and concomitant Radiotherapy 606 Gy 18-2 Gyd or 4515 Gy 15 Gy per fraction twice daily with 4 hours or more between fractions with start at latest at beginning of cycle 3 ideally during cycle 1 and additional Durvalumab 1500 mg once every 3 weeks for 4-6 cycles according to randomization followed by prophylactic cranial irradiation PCI if clinically indicated and according to local standard at any time after completion of radio-chemotherapy
Control group Cisplatin 75 mgm² BSA D1 or alternatively Carboplatin AUC 5 D1 and Etoposide 100 mgm² BSA D1-3 once every 3 weeks for 4-6 cycles and concomitant Radiotherapy 606 Gy 18-2 Gyd or 4515 Gy 15 Gy per fraction twice daily with 4 hours or more between fractions with start at latest at beginning of cycle 3 ideally during cycle 1 followed by prophylactic cranial irradiation PCI if clinically indicated and according to local standard at any time after completion of radio-chemotherapy
Due to the potential toxicity of Cisplatin 75 mgm² D1 a Cisplatin split dose with 40 mgm² on D1 and D8 is alternatively allowed A switch from Cisplatin to Carboplatin AUC 5 D1 due to new contraindication to Cisplatin or split dose Carboplatin AUC 25 D1 and D8 is also allowed In case of initial contraindication to Cisplatin ie renal dysfuction at baseline treatment can be started with Carboplatin once every 3 weeks q21 AUC 5 D1 or split dose AUC 25 D1 and D8 A simultaneous administration of platinum-based chemotherapy preferred Cisplatin and radiotherapy for at least 2 cycles should be performed
Maintenance phase
In Durvalumab group patients will be treated with Durvalumab once every 4 weeks until disease progression radiologic or clinical progression or unacceptable toxicities if patients show at least stable disease after induction phase Patients with PD after induction phase will have EoT visit and will be followed up until death
Patients in control group will have EoT visit and will receive standard of care treatment until PD and thereafter will be followed up until death
show more than 2 AEs CTCAE grade 3 related to study drug Durvalumab
or develop pneumonitis CTCAE grade 2
or drop out Otherwise the trial can continue with randomization Eligible patients will be randomized to Durvalumab group or standard of care group 21
The safety interim analysis was performed in Q4 2021 The independent DMC has recommended the continuation of the trial
Induction phase
Durvalumab group Cisplatin 75 mgm² BSA D1 or alternatively Carboplatin AUC 5 D1 and Etoposide 100 mgm² BSA D1-3 once every 3 weeks for 4-6 cycles and concomitant Radiotherapy 606 Gy 18-2 Gyd or 4515 Gy 15 Gy per fraction twice daily with 4 hours or more between fractions with start at latest at beginning of cycle 3 ideally during cycle 1 and additional Durvalumab 1500 mg once every 3 weeks for 4-6 cycles according to randomization followed by prophylactic cranial irradiation PCI if clinically indicated and according to local standard at any time after completion of radio-chemotherapy
Control group Cisplatin 75 mgm² BSA D1 or alternatively Carboplatin AUC 5 D1 and Etoposide 100 mgm² BSA D1-3 once every 3 weeks for 4-6 cycles and concomitant Radiotherapy 606 Gy 18-2 Gyd or 4515 Gy 15 Gy per fraction twice daily with 4 hours or more between fractions with start at latest at beginning of cycle 3 ideally during cycle 1 followed by prophylactic cranial irradiation PCI if clinically indicated and according to local standard at any time after completion of radio-chemotherapy
Due to the potential toxicity of Cisplatin 75 mgm² D1 a Cisplatin split dose with 40 mgm² on D1 and D8 is alternatively allowed A switch from Cisplatin to Carboplatin AUC 5 D1 due to new contraindication to Cisplatin or split dose Carboplatin AUC 25 D1 and D8 is also allowed In case of initial contraindication to Cisplatin ie renal dysfuction at baseline treatment can be started with Carboplatin once every 3 weeks q21 AUC 5 D1 or split dose AUC 25 D1 and D8 A simultaneous administration of platinum-based chemotherapy preferred Cisplatin and radiotherapy for at least 2 cycles should be performed
Maintenance phase
In Durvalumab group patients will be treated with Durvalumab once every 4 weeks until disease progression radiologic or clinical progression or unacceptable toxicities if patients show at least stable disease after induction phase Patients with PD after induction phase will have EoT visit and will be followed up until death
Patients in control group will have EoT visit and will receive standard of care treatment until PD and thereafter will be followed up until death
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 |
|---|---|---|---|
| 2020-001050-22 | EUDRACT_NUMBER | None | None |