Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

Conditions

• Small Cell Lung Carcinoma Extensive Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab plus chemotherapy — DRUG
  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

Study Details

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.

Key Dates

Start date

Dec 7, 2020

Status verified

Nov 2024

Primary completion

Mar 30, 2023

Completion

Mar 30, 2023

Study Design

Enrollment

166 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab plus 4-6 cycles chemotherapy
  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.

Primary Outcome Measure

Percentage of Participants With Grade ≥3 AEs [ Time Frame: 19 months ]