Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Durvalumab

Etoposide phosphate

Antineoplastic Agents, Immunological

Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.

Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria.

Drug: Carboplatin 4-6 cycles every 3 weeks

Drug: Cisplatin 4-6 cycles every 3 weeks

Drug: Etoposide 4-6 cycles every 3 weeks

Durvalumab plus chemotherapy

This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

An Open Label, Multicenter Study of First-Line Durvalumab Plus Platinum-Based Chemotherapy in Chinese Patients With Extensive Stage Small-Cell Lung Cancer (Oriental)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kaplan-Meier estimate of PFS curve, including quartiles (when estimable) and PFS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.

Kaplan-Meier estimate of the PFS curve at 12 months, together with confidence interval.

The proportion of subjects with an objective response, including confidence interval.

For responders only, the Kaplan Meier curve of DoR including quartiles and DoR at landmark times. All estimates will be accompanied by the appropriate confidence interval.

Kaplan-Meier estimate of OS curve, including quartiles (when estimable) and OS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.

Kaplan-Meier estimate of the OS curve at 12 months, together with confidence interval

Estimates of the incidence of AEs overall, and by different categories of AE

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)	NCT04449861	Small Cell Lung...	Durvalumab plus...	18 Years - 130 Years	AstraZeneca
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)	NCT04449861	Small Cell Lung...	Durvalumab plus...	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for durvalumab plus chemotherapy