NCT04525391

AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer

Phase II, Single-arm Study of AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer Subjects [SUKSES-N5]

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Se-Hoon Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Samsung Medical Centre, Seoul, Korea. Additional 0\~5 Korea Lung Cancer Consortium (KLCC) centres in Korea Up to 40 subjects will be enrolled in two-stages (first stage: 19 evaluable subjects and second stage: 17 evaluable subjects and additional 4 subjects considering the drop out rate) If the study is conducted as de-escalated dosage (Durvalumab 1120mg) after the safety run-in, number of the patients will be counted from the second safety-run in phase.

Detailed description

This study is a single arm, open-label, multi-centre phase II study of AZD2811NP and durvalumab combination therapy in subjects with relapsed small cell lung cancer (SCLC) as a second or third line treatment. Subjects will receive AZD2811 and durvalumab combination therapy. The arm is composed of up to approximately 36 evaluable subjects. After the initiation of the study, a safety run-in period will be conducted with 6 patients to confirm the safety profile. Thus a safety run-in will be undertaken in the first 6 patients with 1500mg of Durvalumab q 3weeks with 500mg of AZD2811. During the safety follow-up, if 2 or more DLT is observed, another safety run-in with new 6 patients will be initiated with 1120mg of Durvalumab q 3weeks with 500mg of AZD2811. In case of a positive risk benefit profile the recruitment will continue. Subjects will receive AZD2811 500mg and durvalumab 1500mg via IV administered on Day 1 for every 3weeks (fixed dosing for subjects \> 30 kg body weight). One cycle consists of 3 weeks. The sequence of the infusion is Durvalumab administered over 1 hour, followed by AZD2811 administered over 2 hours. The optimal proposed time between infusions is 15 min to 30 min. The compatibility of drug products in infusion line has not been tested. Therefore, the infusion line must be flushed with saline after the administration of one drug product and before the start of the second drug product.

Conditions

• SCLC, Recurrent

Interventions

Type	Name	Description
DRUG	Durvalumab+AZD2811 to SCLC patients	AZD2811 must NOT be infused through a 0.2-µm or 0.22-µm filter and therefore durvalumab and AZD2811 MUST be infused through different infusion lines. In order not to exceed the endotoxin limit, durvalumab and AZD2811 mustbe administered consecutively. Durvalumab is administered first over 1 hour, followed by AZD2811 administered over 2 hours. AZD2811 should be administered at 30 minutes after the end of the durvalumab infusion, as long as there are no acute infusion reactions to durvalumab.

Timeline

• Start date: 2020-09-18
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2020-08-25
• Last updated: 2022-02-25

Locations

1 site across 1 country: South Korea