Durvalumab as Consolidation for Patients LS-SCLC | NCT07055581

NCT07055581

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
single arm, multi-center, phase II study	Experimental		Drug: Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance	Drug	Drug: Durvalumab Induction Phase: Durvalumab (1500mg D1 IV Q3W) combined with EP [cisplatin or alternatively Carboplatin (AUC 5-6 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks] for minimum two cycles prior to thoracic radiotherapy Consolidation Phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities or for a maximum of 24 months, whichever occurs first. Drug: Chemotherapy Concomitant chemoradiotherapy consists of further four cycles Etoposide (100 mg/m² D1-3), cisplatin (75 mg/m² D1) /carboplatin (AUC 5-6 D1) q3w Radiation: Thoracic Radiotherapy Radiotherapy to the primary tumor is recommended to start with the 3rd cycle of EP, which can be delayed appropriately per investigator's decision. 60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) or other biologically equivalent regimens will be delivered.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	Defined as the time from first dose of study treatment to date of the first objective disease progression or death from any cause	Every 6weeks from the beginning of Cycle 1(each cycle is 42±7days) in induction phase, every 8weeks(each cycle is 56±7days) in first year and every 12weeks in second year in consolidation phase, thereafter every 24weeks until PD or death,up to 3years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	Defined as the time from first dose of study treatment to date of death from any cause.	Up to 3 years after the first patient was enrolled. OS rate at 1 year(%), 2 years(%) and 3 years(%) are presented.
Objective response rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2.Histologically or cytologically confirmed small cell lung cancer
3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by investigator.
4.Age > 18 years.
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6.Adequate normal organ and marrow function.
7.Must have a life expectancy of at least 12 week.
8.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to enrollment.

Exclusion Criteria:

1.Patients with extensive disease small-cell lung cancer.
2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.
3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology. Patients with mixed histology tumors with predominant SCLC histology are allowed.
4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values.
5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
6.History of allogenic organ transplantation.
7.Active or prior documented autoimmune or inflammatory disorders.
8.Uncontrolled intercurrent illness.
9.History of leptomeningeal carcinomatosis.
10.Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
11.History of active primary immunodeficiency
12.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) and with undetectable HBV DNA (< 10 IU/ml or under the limit of detection per local lab standard) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
13.Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
14.Prior treatment in a previous durvalumab clinical study.
15.Known allergy or hypersensitivity to IP or any excipient.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms